# FDA 510(k) Scraper - Device Clearances & Medtech Intel (`themineworks/fda-510k-device-clearances`) Actor Scrape FDA 510(k) medical device clearances by company, device, or product code. Returns applicant, decision date, decision type & panel for medtech competitive intel and regulatory affairs. No API key. Use it as an MCP server in Claude, ChatGPT & AI agents. - **URL**: https://apify.com/themineworks/fda-510k-device-clearances.md - **Developed by:** [The Mine Works](https://apify.com/themineworks) (community) - **Categories:** Developer tools, MCP servers, Business - **Stats:** 1 total users, 1 monthly users, 0.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing $1.00 / 1,000 clearance scrapeds 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 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 **FDA 510(k) premarket notification clearances** — applicant, device name, decision date, product classification code, and decision type — for every medical device cleared by the FDA since 1976. Built for **medtech competitive intelligence, regulatory affairs, and device market research**. No API key required. **Keywords:** FDA 510k clearances, medical device approvals, openFDA device data, 510k database, medical device regulatory, medtech competitive intelligence. --- ### Why this actor The FDA's 510(k) database is the definitive source for US medical device market clearance history. Whether you are tracking a competitor's product pipeline, monitoring clearance timelines for a product classification, or building a regulatory affairs database, this actor gives you structured access to every 510(k) decision. Uses the official openFDA device/510k endpoint — no scraping, no proxy needed. - **510k clearances going back to 1976**. - **Filter by company, device, or product code** — find every Medtronic, Boston Scientific, or Stryker device cleared in any category. - **Decision type filter** — SE (cleared) vs NSE (not cleared). - **No API key** — openFDA is open. --- ### Input | Field | Type | Default | Description | |---|---|---|---| | `applicant` | string | `Medtronic` | Company name. | | `deviceName` | string | — | Device or product name. | | `productCode` | string | — | FDA 3-letter product code. | | `decisionType` | string | — | SE (cleared) or NSE. | | `dateFrom` | string | `2020-01-01` | Filter decisions from this date. | | `maxResults` | integer | 100 | Max clearances to return (up to 2,000). | --- ### Output ```json { "k_number": "K220456", "applicant": "Medtronic", "device_name": "PUMP, INFUSION, IMPLANTED", "product_code": "KZG", "decision_code": "SE", "decision_description": "Substantially Equivalent", "decision_date": "20220815", "review_panel": "AN", "advisory_committee": "Anesthesiology", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220456", "scraped_at": "2026-06-15T00:00:00.000Z" } ```` *** ### Pricing **First 25 clearances free per account**, then **$0.005 per clearance** ($5 per 1,000). Zero charge on empty runs. *** ### FAQ **What is a 510(k)?** A 510(k) is FDA premarket notification — the approval pathway for medical devices that are substantially equivalent to a legally marketed predicate device. It covers the vast majority of commercial medical devices. **How far back does the data go?** 510(k) records are available from 1976 onward. Date fields use YYYYMMDD format. **What is a product code?** A 3-letter code assigned by FDA to a device type (e.g. FRN = infusion pump, QMF = pulse oximeter). Find product codes at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm. **Can I track all clearances for a competitor?** Yes — set `applicant` to the company name. FDA records the applicant as it appears on the submission, so run multiple variations (e.g. "Medtronic" + "Medtronic Inc" + "Medtronic plc") for complete coverage. **Does this include not-cleared (NSE) decisions?** Yes — set `decisionType: NSE` to retrieve rejected applications. **Who uses this data?** Medtech companies tracking competitor product clearances; regulatory affairs teams benchmarking review timelines; medical device investors monitoring pipeline activity; healthcare consultants advising on market entry. **Can I monitor new clearances automatically?** Yes — schedule this actor weekly on Apify with a `dateFrom` filter set to the rolling current date minus 7 days to receive all new 510(k) decisions in your product category each week. ### Use in Claude, ChatGPT & any MCP agent This actor is also a **Model Context Protocol (MCP) server tool** — call it directly from Claude, ChatGPT, Cursor, Windsurf, or any MCP-compatible AI agent. The agent only pays for results delivered (same pay-per-result model). - Per-actor MCP endpoint: `https://mcp.apify.com/?tools=themineworks/fda-510k-device-clearances` - Full Mine Works MCP server (all tools): `https://the-mine-works-mcp.hatchable.site/api/mcp` ```js // Call this actor as a tool via apify-client (Node) import { ApifyClient } from 'apify-client'; const client = new ApifyClient({ token: 'YOUR_APIFY_TOKEN' }); const run = await client.actor('themineworks/fda-510k-device-clearances').call({ /* input from the table above */ }); const { items } = await client.dataset(run.defaultDatasetId).listItems(); console.log(items); ``` # Actor input Schema ## `applicant` (type: `string`): Company that submitted the 510(k) (e.g. Medtronic, Boston Scientific). ## `deviceName` (type: `string`): Device or product name (partial match). ## `productCode` (type: `string`): FDA 3-letter product classification code (e.g. FRN for infusion pumps). ## `decisionType` (type: `string`): SE = Substantially Equivalent (cleared), NSE = Not Substantially Equivalent. Leave blank for all. ## `dateFrom` (type: `string`): Filter decisions from this date. ## `maxResults` (type: `integer`): Maximum clearances to return. ## Actor input object example ```json { "applicant": "Medtronic", "dateFrom": "2020-01-01", "maxResults": 25 } ``` # 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 = { "applicant": "Medtronic", "dateFrom": "2020-01-01", "maxResults": 25 }; // Run the Actor and wait for it to finish const run = await client.actor("themineworks/fda-510k-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 = { "applicant": "Medtronic", "dateFrom": "2020-01-01", "maxResults": 25, } # Run the Actor and wait for it to finish run = client.actor("themineworks/fda-510k-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 '{ "applicant": "Medtronic", "dateFrom": "2020-01-01", "maxResults": 25 }' | apify call themineworks/fda-510k-device-clearances --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=themineworks/fda-510k-device-clearances", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA 510(k) Scraper - Device Clearances & Medtech Intel", "description": "Scrape FDA 510(k) medical device clearances by company, device, or product code. Returns applicant, decision date, decision type & panel for medtech competitive intel and regulatory affairs. No API key. Use it as an MCP server in Claude, ChatGPT & AI agents.", "version": "0.1", "x-build-id": "VwD3YWGhGHLdx72Ro" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/themineworks~fda-510k-device-clearances/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-themineworks-fda-510k-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": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/themineworks~fda-510k-device-clearances/runs": { "post": { "operationId": "runs-sync-themineworks-fda-510k-device-clearances", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/themineworks~fda-510k-device-clearances/run-sync": { "post": { "operationId": "run-sync-themineworks-fda-510k-device-clearances", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "applicant": { "title": "Applicant / company name", "type": "string", "description": "Company that submitted the 510(k) (e.g. Medtronic, Boston Scientific)." }, "deviceName": { "title": "Device name", "type": "string", "description": "Device or product name (partial match)." }, "productCode": { "title": "Product code", "type": "string", "description": "FDA 3-letter product classification code (e.g. FRN for infusion pumps)." }, "decisionType": { "title": "Decision type", "type": "string", "description": "SE = Substantially Equivalent (cleared), NSE = Not Substantially Equivalent. Leave blank for all." }, "dateFrom": { "title": "Decision date from (YYYY-MM-DD)", "type": "string", "description": "Filter decisions from this date." }, "maxResults": { "title": "Max results", "minimum": 1, "maximum": 2000, "type": "integer", "description": "Maximum clearances 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 } } } } } } } } } } ```