FDA 510(k) Clearances Scraper — Device Approvals

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🎯 What this 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.

⚙️ How to use it

1. Click Try for free at the top of the page.
2. Fill in the input form — most fields have sensible defaults.
3. Click Start. Output streams into the run's dataset.
4. Export from Storage → Dataset as JSON, CSV, or Excel — or fetch via the API.

📥 Input

Field	Type	Required	Default	Notes
applicant	string	no	'Medtronic'	Filter: applicant/company name that filed the 510(k). Matches openFDA's applicant field.
deviceName	string	no	'Cardiac Monitor'	Filter: device name. Matches openFDA's device_name field.
productCode	string	no	'DXH'	Filter: FDA product code. Matches openFDA's product_code field.
advisoryCommittee	string	no	'Cardiovascular'	Filter: advisory committee description. Matches openFDA's advisory_committee_description field.
deviceClass	string	no	'2'	Filter: FDA device class. Matches openFDA's openfda.device_class field.
decisionDateFrom	string	no	'20240101'	Only include clearances decided on or after this date, as YYYYMMDD. Leave empty for no floor.
decisionDateTo	string	no	'20241231'	Only include clearances decided on or before this date, as YYYYMMDD. Leave empty for no ceiling.
searchQuery	string	no	''	Raw openFDA search expression, ANDed with the structured filters above, e.g. decision_code:"SESE". Leave…
maxResults	integer	no	100	Stop after this many records. Each record is one billed result row.
proxyConfiguration	object	no	{'useApifyProxy': False}	openFDA is a public government API and does not need a proxy. Leave this off unless your account requires egress…

Example input

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

📤 Output

Every row is one dataset item.

Field	Type	Notes
k_number	string	openFDA 510(k) submission identifier, e.g. K243021.
applicant	string	Applicant/company that filed the 510(k).
contact	string	Named contact on the submission.
address	string	Applicant address, built from address, city, state, zip and country.
device_name	string	Device name as submitted.
decision_code	string	FDA decision code, e.g. SESE.
decision_date	string	Date FDA decided the submission (YYYY-MM-DD).
decision_description	string	Human-readable decision, e.g. Substantially Equivalent.
product_code	string	FDA product code.
advisory_committee	string	Advisory committee short code.
advisory_committee_description	string	Advisory committee full description, e.g. Cardiovascular.
clearance_type	string	Clearance pathway, e.g. Traditional.
date_received	string	Date FDA received the submission.
expedited_review_flag	string	Whether the submission got expedited review (Y/N).
statement_or_summary	string	Whether a summary or safety/effectiveness statement was filed.
device_class	string	FDA device class — 1, 2 or 3.
medical_specialty_description	string	Medical specialty area, e.g. Cardiovascular.
regulation_number	string	CFR regulation number governing the device, e.g. 870.2300.

Example output

{
  "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

Pay-Per-Event — you pay only when these events fire:

Event	USD	What it is
actor-start	$0.05	One-off warm-up charge per run
result	$0.002	Per dataset item

Example: 1 000 results at the rates above ≈ $2.05. No subscription, no minimum, no card to start — Apify gives every new account $5 of free credit.

🚧 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.

❓ FAQ

Do I need an API key?

No. openFDA serves 510(k) data keylessly; the Actor stays inside the anonymous rate limit.

What's the difference between this and an FDA recalls Actor?

This Actor covers premarket 510(k) clearances — devices getting approved to market. A recalls Actor covers enforcement actions after the fact. They're separate openFDA endpoints with separate row shapes.

Why is there a 25 000 record ceiling?

openFDA's skip parameter refuses to page past 25 000 on this endpoint. The Actor stops cleanly at that boundary and logs it rather than looping or crashing.

💬 Your feedback

Spotted a bug, hit a weird edge case, or need a new field? Open an issue on the Actor's Issues tab on Apify Console — we ship fixes weekly and we read every report.

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