FDA 510(k) Clearances Scraper — Device Approvals

What this Actor scrapes

openFDA publishes every 510(k) premarket clearance the agency has granted — the fastest public record of which device just got cleared to market and who cleared it. The raw API hides a 25 000-record pagination ceiling, an intermittent cold-query 500, and a sparse openfda enrichment block that breaks naive parsers the first time a record ships without it. This Actor normalises all of that into one dependable row shape, so a market-entry or competitive-intelligence watchlist becomes a spreadsheet instead of a scripting project.

What we handle for you

• 🛡️ Browser fingerprint rotation — curl-cffi impersonates real Chrome / Firefox / Safari TLS handshakes on every request.
• 🔁 Retries with exponential backoff on 408 / 429 / 5xx, including openFDA's documented cold-query timeouts — up to 5 attempts per page.
• 🧱 Stops cleanly at openFDA's pagination ceiling instead of looping on a 400, and fails loud (not silently empty) if the endpoint goes down for 3 consecutive pages.
• 🧊 Per-record fault isolation — one malformed record never takes down the run; we skip it, log it, and keep paging.
• 🧊 Clean, typed dataset rows — Pydantic-validated, stable k_number identifiers, JSON / CSV / Excel export straight from the Apify Console.
• 💰 Pay-Per-Event pricing — you only pay for results that hit your dataset. No data, no charge.

Use cases

• Track which devices a competitor just cleared to market, and how fast their submissions move through FDA review.
• Build a market-entry brief on every 510(k) clearance for a product code before entering that device category.
• Feed a due-diligence or investment model with clearance velocity by applicant, advisory committee or device class.
• Monitor a specific device class or committee for new clearances on a recurring schedule.

Input

Paste this into the Apify Console, or send it as the run input over the API. Proxy settings are on by default; you rarely need to touch them.

{
  "deviceClass": "2",
  "maxResults": 3,
  "proxyConfiguration": {
    "useApifyProxy": false
  }
}

Output

One row per result, schema-validated before it is written. Export JSON, CSV, Excel or XML from the run, or read it over the API.

k_numberapplicantcontactaddressdevice_namedecision_codedecision_datedecision_descriptionproduct_codeadvisory_committeeadvisory_committee_descriptionclearance_typedate_receivedexpedited_review_flagstatement_or_summarydevice_class

{
  "k_number": "K243021",
  "applicant": "ACME MEDICAL DEVICES INC.",
  "contact": "JANE DOE",
  "address": "123 MAIN ST, SPRINGFIELD, IL, US",
  "device_name": "ACME CARDIAC MONITOR",
  "decision_code": "SESE",
  "decision_date": "2024-11-15",
  "decision_description": "Substantially Equivalent",
  "product_code": "DXH",
  "advisory_committee": "CV",
  "advisory_committee_description": "Cardiovascular",
  "clearance_type": "Traditional",
  "date_received": "2024-08-01",
  "expedited_review_flag": "N",
  "statement_or_summary": "Summary",
  "device_class": "2",
  "medical_specialty_description": "Cardiovascular",
  "regulation_number": "870.2300"
}

Pricing

You pay only for results that land. Cap any run with maxTotalChargeUsd. See pricing & billing for worked examples.

Limitations

• openFDA caps pagination at 25 000 records per query on this endpoint — narrow the search or the decision-date range to go deeper.
• Filter values aren't escaped for embedded double-quote characters — avoid quotes inside applicant, device name, or committee filters.
• Date fields are passed through in FDA's native string form rather than being reformatted.