# FDA 510(k) Device Clearance Search (`maximedupre/fda-510k`) Actor Search official FDA 510(k) clearances and save structured device, applicant, decision, classification, review, and source data. You can also rank matching clearances by applicant, year, device class, or product code. - **URL**: https://apify.com/maximedupre/fda-510k.md - **Developed by:** [Maxime Dupré](https://apify.com/maximedupre) (community) - **Categories:** Business, Automation, Developer tools - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $1.80 / 1,000 clearances This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events. Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows. In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours, and optionally produces a well-defined JSON output, datasets with results, or files in key-value store. In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server. Actors are written with capital "A". ## How to integrate an Actor? If asked about integration, you help developers integrate Actors into their projects. You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready. The best way to integrate Actors is as follows. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js/docs.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python/docs.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/integrations/mcp.md). If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md). For usage examples, see the [API](#api) section below. For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt). # README ### 🩺 Search official FDA 510(k) device clearances FDA 510(k) Clearance Search helps regulatory, medical device, research, and data teams find official clearance records. Get device, applicant, decision, classification, review, location, and source data, or group matching clearances for analysis. - Find one cleared device with **[FDA 510(k) Clearance](https://apify.com/maximedupre/fda-510k/examples/fda-510k-clearance)**. - Filter official records with **[FDA 510(k) Search](https://apify.com/maximedupre/fda-510k/examples/fda-510k-search)**. - Build a research export from the **[FDA 510(k) Database](https://apify.com/maximedupre/fda-510k/examples/fda-510k-database)**. - Check whether a statement or summary is listed with **[FDA 510(k) Summary](https://apify.com/maximedupre/fda-510k/examples/fda-510k-summary)**. - Look up the FDA record for a **[510k Submission](https://apify.com/maximedupre/fda-510k/examples/510k-submission)**. #### 📦 Returned data Choose **Clearances** to save one row for each matching premarket notification. Each row can include the 510(k) number, device and applicant names, FDA decision, dates, product code, committee, pathway, address, review details, classification details, and an official FDA source link. Choose **Analysis** to rank matching clearance counts by applicant, decision year, device class, or product code. Each row gives the group, count, share, and total matches. Some optional FDA values may be absent. Check the linked FDA source before making legal or regulatory decisions. This Actor does not return full 510(k) summaries, find predicate chains, or compare the 510k vs PMA vs De Novo processes. #### ▶️ Running the Actor 1. Choose **Clearances** or **Analysis**. 2. Fill one or more filters. Filled filters work together. 3. For Clearances, set a result limit or leave it empty. 4. For Analysis, choose the field used to group the matches. 5. Run the Actor and open the default dataset. No FDA API key or FDA sign-in is needed. #### ⚙️ Input | Field | Type | What it does | |---|---|---| | `target` | string | Chooses clearance rows or grouped analysis rows. | | `maxItems` | integer | Stops after this many clearance records. It is used only for Clearances. Leave it empty to return all available results until the source is exhausted. | | `groupBy` | string | Groups Analysis by applicant, decision year, device class, or product code. | | `deviceName` | string | Finds device names that contain this text. | | `applicant` | string | Finds applicant names that contain this text. | | `productCode` | string | Matches one exact three-letter FDA product code. | | `kNumber` | string | Matches one exact 510(k) number. | | `decisionDateFrom` | string | Keeps decisions on or after this date. | | `decisionDateTo` | string | Keeps decisions on or before this date. | | `advisoryCommittee` | string | Matches an FDA committee name or code. | | `decision` | string | Matches an FDA decision outcome. | | `clearanceType` | string | Matches a clearance pathway. | | `applicantCountry` | string | Matches the applicant country name. | This successful default-input run searches for cardiac clearances and saves up to five rows: ```json { "target": "clearances", "maxItems": 5, "groupBy": "applicant", "deviceName": "cardiac" } ```` #### 📤 Output Clearance rows use this shape: | Field | Type | What it does | |---|---|---| | `resultType` | string | Shows that the row is a clearance. | | `kNumber` | string | Gives the FDA 510(k) number. | | `deviceName` | string | Gives the device name. | | `applicant` | string | Gives the applicant name. | | `decision` | string | Gives the FDA decision. | | `decisionDate` | string | Gives the FDA decision date. | | `productCode` | string | Gives the three-letter FDA product code. | | `advisoryCommittee` | string | Gives the FDA committee name or code. | | `clearanceType` | string | Gives the clearance pathway. | | `applicantLocation` | object | Holds the available applicant address. | | `applicantLocation.street1` | string | Gives the first street line. | | `applicantLocation.street2` | string | Gives the second street line. | | `applicantLocation.city` | string | Gives the city. | | `applicantLocation.state` | string | Gives the state or region. | | `applicantLocation.postalCode` | string | Gives the postal code. | | `applicantLocation.country` | string | Gives the FDA country name or code. | | `dateReceived` | string | Gives the date FDA received the submission. | | `reviewDays` | integer | Gives calendar days from receipt to decision. | | `statementOrSummary` | string | Says whether FDA lists a statement or summary. | | `contact` | string | Gives the applicant contact listed by FDA. | | `thirdPartyReview` | boolean | Says whether third-party review was used. | | `expeditedReview` | boolean | Says whether expedited review was used. | | `classification` | object | Holds available FDA classification details. | | `classification.deviceClass` | string | Gives the FDA device class. | | `classification.regulationNumber` | string | Gives the FDA regulation number. | | `classification.deviceName` | string | Gives the standard classification name. | | `classification.medicalSpecialty` | string | Gives the medical specialty. | | `sourceUrl` | string | Links to the official FDA clearance page. | ```json { "resultType": "clearance", "kNumber": "K261569", "deviceName": "UbiqVue™ 2AYe Cardiac System (UX2253)", "applicant": "Lifesignals, Inc.", "decision": "Substantially Equivalent", "decisionDate": "2026-07-09", "productCode": "DRG", "advisoryCommittee": "CV", "clearanceType": "Traditional", "applicantLocation": { "street1": "426 S Hillview Dr.", "city": "Milpitas", "state": "CA", "postalCode": "95035", "country": "US" }, "dateReceived": "2026-05-12", "reviewDays": 58, "statementOrSummary": "Summary", "contact": "Saravanan Balasubramanian", "thirdPartyReview": false, "classification": { "deviceClass": "2", "regulationNumber": "870.2910", "deviceName": "Transmitters And Receivers, Physiological Signal, Radiofrequency", "medicalSpecialty": "Cardiovascular" }, "sourceUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K261569" } ``` Analysis rows use this shape: | Field | Type | What it does | |---|---|---| | `resultType` | string | Shows that the row is an analysis group. | | `groupBy` | string | Gives the field used to group matches. | | `groupValue` | string | Gives the value shared by this group. | | `count` | integer | Gives the number of matching clearances in the group. | | `share` | number | Gives the group's part of all matches, from 0 to 1. | | `total` | integer | Gives the total number of matching clearances. | ```json { "resultType": "analysis", "groupBy": "decisionYear", "groupValue": "2024", "count": 7, "share": 1, "total": 7 } ``` #### 💳 Pricing This Actor uses pay-per-event pricing. A charge applies to each clearance row saved in a Clearances run and each ranked group saved in an Analysis run. Runs with no saved rows do not create either of these charges. See the pricing tab for current rates. #### 🔌 Integrations Run the Actor in Apify Console, through the Apify API or MCP, on a schedule, or from another Actor. Export the default dataset in formats supported by Apify or connect it to your workflow. https://www.youtube.com/watch?v=bNACk1\_S\_6w\&list=PLObrtcm1Kw6MUrlLNDbK9QRg8VDJg0gOW\&index=4 #### ❓ FAQ ##### Can this help with a 510k submission? It can help you research clearance records and check official source pages. It does not prepare or file a submission. ##### Does it return the full FDA 510k summary? No. It returns the FDA value that says whether a summary or statement is available and links to the official clearance page. ##### Can it explain 510k vs PMA? No. It searches the 510(k) clearance corpus. It does not compare FDA regulatory pathways. ##### Can I search part of a device or applicant name? Yes. Device and applicant fields support partial text. Product codes and 510(k) numbers use exact lookup values. ##### What happens when an optional FDA field is missing? The clearance can still be returned. Optional fields appear only when the source provides them. ##### Does the Actor need an FDA API key? No. It reads public FDA data without credentials supplied by you. ### 📝 Changelog #### 0.0: Initial release - Search and analyze official FDA 510(k) clearance records with structured device, applicant, decision, classification, review, and source data. ### 🆘 Support For issues, questions, or feature requests, [file a ticket](https://console.apify.com/actors/maximedupre~fda-510k/issues) and I'll fix or implement it in less than 24h 🫡 ### 🔗 Related Actors - [ClinicalTrials.gov](https://apify.com/maximedupre/clinicaltrials-gov) — find studies linked to devices, sponsors, conditions, and interventions. - [FDA Food Recall Monitor](https://apify.com/maximedupre/fda-food-recalls-scraper) — search official FDA food enforcement recalls and track changes. - [FDA 510k Device Clearance Monitor](https://apify.com/technicaldost/fda-device-510k-monitor) — monitor recent openFDA device clearances. - [FDA 510(k) Scraper - Medical Device Clearance API](https://apify.com/pink_comic/fda-510k-medical-device-clearances) — search related clearance fields through another Store tool. - [FDA 510(k) Device Clearance Search](https://apify.com/ryanclinton/fda-510k-clearances) — compare a clearance search that also offers grouped output. **Made with ❤️ by Maxime Dupré** # Actor input Schema ## `target` (type: `string`): Choose clearance records or a count analysis of matching records. ## `maxItems` (type: `integer`): Stop after this many clearance records. This field is used only for Clearances. Leave it blank to return all available records until the source is exhausted. ## `groupBy` (type: `string`): Rank matching clearance counts by this field. Each group includes its count, share, and the total matching population. ## `deviceName` (type: `string`): Find device names that contain this text. ## `applicant` (type: `string`): Find applicant names that contain this text. ## `productCode` (type: `string`): Match one exact three-letter FDA product classification code, such as DQY. ## `kNumber` (type: `string`): Match one exact 510(k) number, such as K240001. ## `decisionDateFrom` (type: `string`): Keep clearances decided on or after this date. ## `decisionDateTo` (type: `string`): Keep clearances decided on or before this date. ## `advisoryCommittee` (type: `string`): Match an FDA advisory committee name or code. ## `decision` (type: `string`): Match an FDA decision outcome, such as Substantially Equivalent. ## `clearanceType` (type: `string`): Match a clearance pathway, such as Traditional, Special, or Abbreviated. ## `applicantCountry` (type: `string`): Match the applicant's country name. ## Actor input object example ```json { "target": "clearances", "maxItems": 5, "groupBy": "applicant", "deviceName": "cardiac" } ``` # Actor output Schema ## `results` (type: `string`): The clearance records or count groups saved in the default dataset. # API You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup. ## JavaScript example ```javascript import { ApifyClient } from 'apify-client'; // Initialize the ApifyClient with your Apify API token // Replace the '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "target": "clearances", "maxItems": 5, "groupBy": "applicant", "deviceName": "cardiac" }; // Run the Actor and wait for it to finish const run = await client.actor("maximedupre/fda-510k").call(input); // Fetch and print Actor results from the run's dataset (if any) console.log('Results from dataset'); console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`); const { items } = await client.dataset(run.defaultDatasetId).listItems(); items.forEach((item) => { console.dir(item); }); // 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs ``` ## Python example ```python from apify_client import ApifyClient # Initialize the ApifyClient with your Apify API token # Replace '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "target": "clearances", "maxItems": 5, "groupBy": "applicant", "deviceName": "cardiac", } # Run the Actor and wait for it to finish run = client.actor("maximedupre/fda-510k").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "target": "clearances", "maxItems": 5, "groupBy": "applicant", "deviceName": "cardiac" }' | apify call maximedupre/fda-510k --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=maximedupre/fda-510k", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA 510(k) Device Clearance Search", "description": "Search official FDA 510(k) clearances and save structured device, applicant, decision, classification, review, and source data. You can also rank matching clearances by applicant, year, device class, or product code.", "version": "0.0", "x-build-id": "xChEAEhRdo292ZNmo" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/maximedupre~fda-510k/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-maximedupre-fda-510k", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/maximedupre~fda-510k/runs": { "post": { "operationId": "runs-sync-maximedupre-fda-510k", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/maximedupre~fda-510k/run-sync": { "post": { "operationId": "run-sync-maximedupre-fda-510k", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "required": [ "target" ], "properties": { "target": { "title": "Target", "enum": [ "clearances", "analysis" ], "type": "string", "description": "Choose clearance records or a count analysis of matching records.", "default": "clearances" }, "maxItems": { "title": "Result limit", "minimum": 1, "type": "integer", "description": "Stop after this many clearance records. This field is used only for Clearances. Leave it blank to return all available records until the source is exhausted." }, "groupBy": { "title": "Group results by", "enum": [ "applicant", "decisionYear", "deviceClass", "productCode" ], "type": "string", "description": "Rank matching clearance counts by this field. Each group includes its count, share, and the total matching population.", "default": "applicant" }, "deviceName": { "title": "Device name", "type": "string", "description": "Find device names that contain this text.", "default": "cardiac" }, "applicant": { "title": "Applicant", "type": "string", "description": "Find applicant names that contain this text." }, "productCode": { "title": "FDA product code", "pattern": "^[A-Za-z]{3}$", "type": "string", "description": "Match one exact three-letter FDA product classification code, such as DQY." }, "kNumber": { "title": "510(k) number", "pattern": "^[Kk][0-9]{6}$", "type": "string", "description": "Match one exact 510(k) number, such as K240001." }, "decisionDateFrom": { "title": "Decision date from", "pattern": "^[0-9]{4}-[0-9]{2}-[0-9]{2}$", "type": "string", "description": "Keep clearances decided on or after this date." }, "decisionDateTo": { "title": "Decision date to", "pattern": "^[0-9]{4}-[0-9]{2}-[0-9]{2}$", "type": "string", "description": "Keep clearances decided on or before this date." }, "advisoryCommittee": { "title": "Advisory committee", "type": "string", "description": "Match an FDA advisory committee name or code." }, "decision": { "title": "FDA decision", "type": "string", "description": "Match an FDA decision outcome, such as Substantially Equivalent." }, "clearanceType": { "title": "Clearance pathway", "type": "string", "description": "Match a clearance pathway, such as Traditional, Special, or Abbreviated." }, "applicantCountry": { "title": "Applicant country", "type": "string", "description": "Match the applicant's country name." } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```