# FDA 510(k) Device Clearance Landscape Report (`taroyamada/fda-510k-device-clearance-landscape-report`) Actor Analyze official openFDA 510(k) clearance records by applicant, device name, product code, specialty, and decision date. Receive source-linked clearance change alerts, landscape reports, and exports from public records. Baselines and unchanged checks are free. - **URL**: https://apify.com/taroyamada/fda-510k-device-clearance-landscape-report.md - **Developed by:** [naoki anzai](https://apify.com/taroyamada) (community) - **Categories:** Business - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $4.00 / 1,000 fda 510(k) rows This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events. 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 ## FDA 510(k) Device Clearance Landscape Report Medtech competitive-intelligence, regulatory-operations, and portfolio-strategy teams enter bounded 510(k) watches for applicants, product codes, device names, specialties, or dates. The Actor queries the official openFDA device/510k API and compares each public record with an isolated recurring baseline. It returns source-linked clearance change alerts, applicant/product-code/specialty landscape reports, and JSON exports; baseline and unchanged checks emit zero rows and zero charges. ### Store Quickstart 1. Start with `initialRunMode: "baseline_only"` to establish a free snapshot. 2. Run the same `monitorKey` later with `generateReport: true` and `emitUnchanged: false`. 3. Use `initialRunMode: "emit_backfill"` only when you explicitly want the current matching records and a paid report immediately. The Actor uses `https://api.fda.gov/device/510k.json`. An openFDA API key is optional; normal bounded runs work without one. The optional `openfdaApiKey` input is never written to output or monitor state. ### Input Examples #### 1. Product-code watch ```json { "watches": [{ "id": "diagnostic-imaging", "productCodes": ["LLZ"], "decisionDateFrom": "2026-01-01", "decisionDateTo": "2026-12-31" }], "monitorKey": "diagnostic-imaging-2026", "initialRunMode": "baseline_only", "generateReport": true, "emitUnchanged": false, "maxRecordsPerWatch": 100, "maxChargeUsd": 25 } ```` #### 2. Applicant and specialty watch ```json { "watches": [{ "id": "company-radiology", "applicants": ["Example Device Company"], "medicalSpecialties": ["Radiology"], "decisionDateFrom": "2025-01-01", "decisionDateTo": "2026-12-31" }], "monitorKey": "company-radiology-watch", "initialRunMode": "emit_backfill", "generateReport": true, "emitExport": true, "emitRawRows": false, "maxChargeUsd": 25 } ``` #### 3. Device and review-panel watch ```json { "watches": [{ "id": "portable-device-panel", "deviceNames": ["portable monitor"], "reviewPanels": ["Cardiovascular"], "clearanceTypes": ["Traditional"] }], "monitorKey": "portable-device-panel", "initialRunMode": "baseline_only", "generateReport": true, "emitUnchanged": false } ``` ### Output The primary value rows are: - `fda-clearance-change-alert`: one source-linked alert for a new or changed public record. - `fda-clearance-landscape-report`: an aggregate grouped by applicant, product code, specialty, decision date, and review panel. - `fda-clearance-export`: a compact JSON-ready set of normalized records. - `fda-510k-row`: optional low-priced normalized record rows when `emitRawRows` is true. Normalized records contain public analysis fields such as `kNumber`, `applicant`, `deviceName`, `productCode`, `medicalSpecialty`, `decisionDate`, `decisionCode`, `clearanceType`, `reviewPanel`, and `regulationNumbers`. Direct communication and contact fields are not emitted. See [`docs/sample-output.json`](docs/sample-output.json) for a representative alert, report, export, and row payload. It is illustrative and is not a live FDA result. ### Pricing | Event | Price | When it is emitted | | --- | ---: | --- | | `fda-510k-row` | `$0.004` | Optional normalized row for a new or changed record | | `fda-clearance-change-alert` | `$0.20` | New or changed record is detected | | `fda-clearance-landscape-report` | `$10.00` | An explicit change set is summarized | | `fda-clearance-export` | `$6.00` | An explicit change set is exported | There is no start charge. A first `baseline_only` run saves state and emits `0 rows / 0 charge`. A later unchanged run also emits `0 rows / 0 charge`, regardless of `emitUnchanged`. `maxChargeUsd` is checked before any row is pushed; a state-save failure fails closed and does not report a successful run. ### Compliance Guardrails - Official public openFDA device/510k data only; no login, browser session, proxy, or bypass is used. - Public applicant and product names are retained for record analysis, not for person enrichment or contact workflows. - The Actor does not provide medical, legal, regulatory, compliance, investment, procurement, or market-access advice. - It does not claim FDA endorsement, approval superiority, safety, efficacy, causality, or clearance likelihood. - Verify the official source record and consult qualified professionals before making a decision. See [`docs/source-compliance.md`](docs/source-compliance.md) for source scope and limitations. ### Run the next report - [FDA Orange Book Patent & Exclusivity Change Report](https://apify.com/taroyamada/fda-orange-book-patent-exclusivity-change-report) for public drug patent, exclusivity, and product-lifecycle change reporting. - [Product Safety Market Action Portfolio Report](https://apify.com/taroyamada/product-safety-market-action-portfolio-report) for CPSC and NHTSA public market-action evidence. - [FDA Drug Shortage Supply Change Report](https://apify.com/taroyamada/fda-drug-shortage-supply-change-report) for source-linked public drug-shortage changes and supply reports. ### Source - [openFDA 510(k) endpoint](https://api.fda.gov/device/510k.json) - [openFDA 510(k) API guide](https://open.fda.gov/apis/device/510k/how-to-use-the-endpoint/) - [openFDA 510(k) searchable fields](https://open.fda.gov/apis/device/510k/searchable-fields/) # Actor input Schema ## `watches` (type: `array`): Bounded saved searches by applicant, product code, device name, medical specialty, review panel, clearance type, decision code, regulation number, or decision date. ## `monitorKey` (type: `string`): Stable isolated state namespace for a recurring saved clearance watch. ## `initialRunMode` (type: `string`): baseline\_only stores the first observation with zero rows; emit\_backfill emits current matches for an explicit first report. ## `generateReport` (type: `boolean`): Generate one aggregate applicant/product-code/specialty landscape report when new or changed observations are emitted. ## `emitRawRows` (type: `boolean`): Emit one normalized public 510(k) row for each new or changed record. This is the low-priced row event. ## `emitExport` (type: `boolean`): Generate a compact JSON-ready export when new or changed observations are emitted. ## `emitUnchanged` (type: `boolean`): Accepted for compatibility, but unchanged observations always remain zero rows and zero charge for billing safety. ## `maxRecordsPerWatch` (type: `integer`): Maximum records requested from openFDA per watch. The official API maximum is 1000. ## `maxChargeUsd` (type: `number`): Fail closed before pushing any row if planned PPE charges exceed this cap. ## `openfdaApiKey` (type: `string`): Optional user-supplied free openFDA key. Leave blank: normal use does not require a key. The key is never written to output or state. ## `dryRun` (type: `boolean`): Return representative event rows without calling openFDA, saving state, or charging PPE events. ## Actor input object example ```json { "watches": [ { "id": "diagnostic-imaging-2026", "productCodes": [ "LLZ" ], "decisionDateFrom": "2026-01-01", "decisionDateTo": "2026-12-31" } ], "monitorKey": "fda-510k-clearance-watch", "initialRunMode": "baseline_only", "generateReport": true, "emitRawRows": false, "emitExport": false, "emitUnchanged": false, "maxRecordsPerWatch": 100, "maxChargeUsd": 25, "dryRun": false } ``` # Actor output Schema ## `results` (type: `string`): Source-linked FDA 510(k) alerts, landscape reports, and optional exports written to the run 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 = { "watches": [ { "id": "diagnostic-imaging-2026", "productCodes": [ "LLZ" ], "decisionDateFrom": "2026-01-01", "decisionDateTo": "2026-12-31" } ] }; // Run the Actor and wait for it to finish const run = await client.actor("taroyamada/fda-510k-device-clearance-landscape-report").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 = { "watches": [{ "id": "diagnostic-imaging-2026", "productCodes": ["LLZ"], "decisionDateFrom": "2026-01-01", "decisionDateTo": "2026-12-31", }] } # Run the Actor and wait for it to finish run = client.actor("taroyamada/fda-510k-device-clearance-landscape-report").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 '{ "watches": [ { "id": "diagnostic-imaging-2026", "productCodes": [ "LLZ" ], "decisionDateFrom": "2026-01-01", "decisionDateTo": "2026-12-31" } ] }' | apify call taroyamada/fda-510k-device-clearance-landscape-report --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=taroyamada/fda-510k-device-clearance-landscape-report", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA 510(k) Device Clearance Landscape Report", "description": "Analyze official openFDA 510(k) clearance records by applicant, device name, product code, specialty, and decision date. Receive source-linked clearance change alerts, landscape reports, and exports from public records. Baselines and unchanged checks are free.", "version": "0.1", "x-build-id": "TOyIyRrbenXbH2hMv" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/taroyamada~fda-510k-device-clearance-landscape-report/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-taroyamada-fda-510k-device-clearance-landscape-report", "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": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/taroyamada~fda-510k-device-clearance-landscape-report/runs": { "post": { "operationId": "runs-sync-taroyamada-fda-510k-device-clearance-landscape-report", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/taroyamada~fda-510k-device-clearance-landscape-report/run-sync": { "post": { "operationId": "run-sync-taroyamada-fda-510k-device-clearance-landscape-report", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": [ "watches" ], "properties": { "watches": { "title": "510(k) watches", "type": "array", "description": "Bounded saved searches by applicant, product code, device name, medical specialty, review panel, clearance type, decision code, regulation number, or decision date.", "items": { "type": "object", "properties": { "id": { "title": "Watch ID", "description": "Stable identifier for this recurring watch.", "type": "string" }, "applicants": { "title": "Applicants", "description": "Public applicant/company names as recorded in openFDA.", "type": "array", "items": { "type": "string" } }, "productCodes": { "title": "Product codes", "description": "FDA three-character product codes, for example OVE or DQY.", "type": "array", "items": { "type": "string" } }, "deviceNames": { "title": "Device names", "description": "Public device-name fragments.", "type": "array", "items": { "type": "string" } }, "medicalSpecialties": { "title": "Medical specialties", "description": "Public openFDA medical specialty values.", "type": "array", "items": { "type": "string" } }, "reviewPanels": { "title": "Review panels", "description": "Public 510(k) review panel values.", "type": "array", "items": { "type": "string" } }, "clearanceTypes": { "title": "Clearance types", "description": "Public clearance type values.", "type": "array", "items": { "type": "string" } }, "decisionCodes": { "title": "Decision codes", "description": "Public 510(k) decision codes.", "type": "array", "items": { "type": "string" } }, "regulationNumbers": { "title": "Regulation numbers", "description": "Exact openFDA regulation numbers.", "type": "array", "items": { "type": "string" } }, "terms": { "title": "Search terms", "description": "Public device-name or statement fragments searched across the 510(k) record.", "type": "array", "items": { "type": "string" } }, "decisionDateFrom": { "title": "Decision date from", "description": "Inclusive ISO date, YYYY-MM-DD.", "type": "string", "pattern": "^\\d{4}-\\d{2}-\\d{2}$" }, "decisionDateTo": { "title": "Decision date to", "description": "Inclusive ISO date, YYYY-MM-DD.", "type": "string", "pattern": "^\\d{4}-\\d{2}-\\d{2}$" } }, "additionalProperties": false }, "default": [] }, "monitorKey": { "title": "Monitor key", "type": "string", "description": "Stable isolated state namespace for a recurring saved clearance watch.", "default": "fda-510k-clearance-watch" }, "initialRunMode": { "title": "Initial run mode", "enum": [ "baseline_only", "emit_backfill" ], "type": "string", "description": "baseline_only stores the first observation with zero rows; emit_backfill emits current matches for an explicit first report.", "default": "baseline_only" }, "generateReport": { "title": "Generate clearance landscape report", "type": "boolean", "description": "Generate one aggregate applicant/product-code/specialty landscape report when new or changed observations are emitted.", "default": true }, "emitRawRows": { "title": "Emit 510(k) rows", "type": "boolean", "description": "Emit one normalized public 510(k) row for each new or changed record. This is the low-priced row event.", "default": false }, "emitExport": { "title": "Generate clearance export", "type": "boolean", "description": "Generate a compact JSON-ready export when new or changed observations are emitted.", "default": false }, "emitUnchanged": { "title": "Emit unchanged observations", "type": "boolean", "description": "Accepted for compatibility, but unchanged observations always remain zero rows and zero charge for billing safety.", "default": false }, "maxRecordsPerWatch": { "title": "Maximum records per watch", "minimum": 1, "maximum": 1000, "type": "integer", "description": "Maximum records requested from openFDA per watch. The official API maximum is 1000.", "default": 100 }, "maxChargeUsd": { "title": "Maximum charge USD", "minimum": 0.004, "maximum": 250, "type": "number", "description": "Fail closed before pushing any row if planned PPE charges exceed this cap.", "default": 25 }, "openfdaApiKey": { "title": "Optional openFDA API key", "type": "string", "description": "Optional user-supplied free openFDA key. Leave blank: normal use does not require a key. The key is never written to output or state." }, "dryRun": { "title": "Dry run", "type": "boolean", "description": "Return representative event rows without calling openFDA, saving state, or charging PPE events.", "default": false } } }, "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 } } } } } } } } } } ```