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.

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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.

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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).

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Output

{
  "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"
}

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Pricing

First 25 clearances free per account, then $0.005 per clearance ($5 per 1,000). Zero charge on empty runs.

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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

// 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);