# FDA 510(k) Medical Device Clearances | $0.002 (`pink_comic/fda-510k-medical-device-clearances`) Actor Search FDA 510(k) medical device clearances. Returns device name, applicant, decision date, product code, and clearance status. Built for regulatory affairs and market research teams. Pay per result. - **URL**: https://apify.com/pink\_comic/fda-510k-medical-device-clearances.md - **Developed by:** [Ava Torres](https://apify.com/pink_comic) (community) - **Categories:** Business, Automation, MCP servers - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, NaN bookmarks - **User rating**: No ratings yet ## Pricing Pay per usage This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-usage ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.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/platform/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 ## FDA 510(k) Medical Device Clearances Search the FDA 510(k) premarket notification database for medical device clearances and approvals. This actor uses the official OpenFDA API -- no API key required. ### Use Cases - **Medical device companies** -- Monitor competitor device clearances, track new entrants in your product category, and identify predicate devices for your own 510(k) submissions. - **Healthcare investors** -- Screen for newly cleared devices by company or product category. Identify companies with active FDA pipelines and track approval timelines. - **Regulatory consultants** -- Research clearance history for specific device types, find predicate devices, and analyze decision patterns by product code or advisory committee. - **Competitor intelligence** -- Track which companies are getting clearances in your space, how quickly decisions are made, and what device names are entering the market. - **Supply chain and procurement** -- Identify cleared medical device suppliers by location, product code, or device category. ### Input Parameters | Parameter | Description | Example | |-----------|-------------|---------| | **Device Name** | Search by device name | `stent`, `catheter`, `implant` | | **Applicant** | Search by company name | `medtronic`, `boston scientific` | | **Product Code** | Search by FDA product code | `DZE`, `NIQ` | | **Date From** | Start of decision date range (YYYY-MM-DD) | `2024-01-01` | | **Date To** | End of decision date range (YYYY-MM-DD) | `2024-12-31` | | **Max Results** | Maximum results to return (1-10000) | `100` | At least one of Device Name, Applicant, or Product Code is required. ### Output Fields Each result includes: - **kNumber** -- The 510(k) submission number (e.g. K241234) - **deviceName** -- Name of the device - **applicant** -- Company that submitted the application - **decisionDate** -- Date the FDA made its decision - **decisionCode** -- Decision code (SESE = Substantially Equivalent, SESD = Substantially Equivalent with limitations, etc.) - **decisionDescription** -- Human-readable decision description - **productCode** -- FDA product classification code - **advisoryCommittee** -- FDA advisory committee that reviewed the device - **clearanceType** -- Type of clearance - **city**, **state**, **countryCode** -- Applicant location - **statementOrSummary** -- Whether a summary or statement was provided ### Example Search for stent clearances in 2024: ```json { "deviceName": "stent", "dateFrom": "2024-01-01", "dateTo": "2024-12-31", "maxResults": 50 } ```` ### Data Source This actor uses the [OpenFDA Device 510(k) API](https://open.fda.gov/apis/device/510k/), a free public API provided by the U.S. Food and Drug Administration. No API key or authentication is required. # Actor input Schema ## `deviceName` (type: `string`): Search by device name (e.g. "stent", "catheter", "implant"). ## `applicant` (type: `string`): Search by applicant or company name (e.g. "medtronic", "boston scientific"). ## `productCode` (type: `string`): Search by FDA product code (e.g. "DZE", "NIQ"). ## `dateFrom` (type: `string`): Start date for decision date range in YYYY-MM-DD format (e.g. "2024-01-01"). ## `dateTo` (type: `string`): End date for decision date range in YYYY-MM-DD format (e.g. "2024-12-31"). ## `maxResults` (type: `integer`): Maximum number of results to return. ## Actor input object example ```json { "deviceName": "stent", "applicant": "", "productCode": "", "dateFrom": "", "dateTo": "", "maxResults": 100 } ``` # 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 = { "deviceName": "stent", "applicant": "", "productCode": "", "dateFrom": "", "dateTo": "", "maxResults": 100 }; // Run the Actor and wait for it to finish const run = await client.actor("pink_comic/fda-510k-medical-device-clearances").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 = { "deviceName": "stent", "applicant": "", "productCode": "", "dateFrom": "", "dateTo": "", "maxResults": 100, } # Run the Actor and wait for it to finish run = client.actor("pink_comic/fda-510k-medical-device-clearances").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 '{ "deviceName": "stent", "applicant": "", "productCode": "", "dateFrom": "", "dateTo": "", "maxResults": 100 }' | apify call pink_comic/fda-510k-medical-device-clearances --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=pink_comic/fda-510k-medical-device-clearances", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA 510(k) Medical Device Clearances | $0.002", "description": "Search FDA 510(k) medical device clearances. Returns device name, applicant, decision date, product code, and clearance status. Built for regulatory affairs and market research teams. Pay per result.", "version": "0.1", "x-build-id": "Cus9bO2aLJdefyKoP" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/pink_comic~fda-510k-medical-device-clearances/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-pink_comic-fda-510k-medical-device-clearances", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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/pink_comic~fda-510k-medical-device-clearances/runs": { "post": { "operationId": "runs-sync-pink_comic-fda-510k-medical-device-clearances", "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/pink_comic~fda-510k-medical-device-clearances/run-sync": { "post": { "operationId": "run-sync-pink_comic-fda-510k-medical-device-clearances", "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", "properties": { "deviceName": { "title": "Device Name", "type": "string", "description": "Search by device name (e.g. \"stent\", \"catheter\", \"implant\").", "default": "stent" }, "applicant": { "title": "Applicant / Company", "type": "string", "description": "Search by applicant or company name (e.g. \"medtronic\", \"boston scientific\").", "default": "" }, "productCode": { "title": "Product Code", "type": "string", "description": "Search by FDA product code (e.g. \"DZE\", \"NIQ\").", "default": "" }, "dateFrom": { "title": "Date From", "type": "string", "description": "Start date for decision date range in YYYY-MM-DD format (e.g. \"2024-01-01\").", "default": "" }, "dateTo": { "title": "Date To", "type": "string", "description": "End date for decision date range in YYYY-MM-DD format (e.g. \"2024-12-31\").", "default": "" }, "maxResults": { "title": "Max Results", "minimum": 1, "maximum": 10000, "type": "integer", "description": "Maximum number of results to return.", "default": 100 } } }, "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 } } } } } } } } } } ```