🛡️ FDA 510(k) Device Clearances

Clean, structured records of medical-device 510(k) clearances, sourced live from the official openFDA device 510(k) API (https://api.fda.gov/device/510k.json) — an anonymous, documented U.S. Food & Drug Administration endpoint. One record per cleared device (K-number), deduplicated, with the FDA's own fields carried exactly as published.

Output is one device_clearance row per result; billing is pay-per-event, the value event being one device clearance (a $0.02 start fee per run, then $0.05 per device clearance). Source: api.fda.gov, www.accessdata.fda.gov.

No login, no API key and no CAPTCHA solving are involved: the source is read logged-out.

📊 Sample Output

Real rows from run G9h4MhnmezGFr9HGD on build 0.1.9 (2026-09-17), the same input as the Quick start below — every value is as the source published it (emails masked, long text shortened):

applicant	decision_date	decision_type	clearance_type	advisory_committee	applicant_location
Shenzhen Osto Medical Technology Co.,Ltd	2026-09-06	Substantially Equivalent	Traditional	Neurology	Shenzhen, CN
Fidelity BioPharma Co.	2026-09-06	Substantially Equivalent	Traditional	Neurology	New Haven, CT, US
NOUVAG AG	2026-09-05	Substantially Equivalent	Traditional	General, Plastic Surgery	Sankt Gallen, CH
Cryosurgery, Inc.	2026-09-05	Substantially Equivalent	Traditional	Unknown	Nashville, TN, US
Alimetry , Ltd.	2026-09-04	Substantially Equivalent	Traditional	Gastroenterology, Urology	Auckland, NZ
Radiopharmaceutical Imaging & Dosimetry, LLC	2026-09-04	Substantially Equivalent	Traditional	Radiology	Baltimore, MD, US
Dentsply Sirona, Inc.	2026-09-04	Substantially Equivalent	Traditional	General Hospital	York, PA, US
Sentinel Medical Technologies,	2026-09-04	Substantially Equivalent	Traditional	Gastroenterology, Urology	Jacksonville, FL, US

The run finished with the status message: CAPPED: delivered 10 of at least 11 unique clearances (maxRecords=10) — a buyer-requested bound, not an outage. read 11 page(s), 0 duplicate K-numbers collapsed. device_clearance billable=10

✅ What you get

Each row is flat JSON with these fields (from the dataset schema and the sample run; a field the source does not publish for a given row is null):

• record_type (string) — e.g. device_clearance
• k_number (string/null) — e.g. K261131
• applicant (string/null) — e.g. Shenzhen Osto Medical Technology Co.,Ltd
• device_name (string/null) — e.g. Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-3
• product_code (string/null) — e.g. NUH
• decision_date (string/null) — e.g. 2026-09-06
• decision_code (string/null) — e.g. SESE
• decision_type (string/null) — e.g. Substantially Equivalent
• clearance_type (string/null) — e.g. Traditional
• advisory_committee (string/null) — e.g. Neurology
• expedited_review (string/null) — null in every sample row
• third_party_review (string/null) — e.g. N
• statement_or_summary (string/null) — e.g. Statement
• applicant_location (string/null) — e.g. Shenzhen, CN
• date_received (string/null) — e.g. 2026-04-06
• predicate_k_number (string/null) — null in every sample row
• source (string/null) — e.g. openfda-device-510k
• source_url (string/null) — e.g. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261131
• observed_at (string/null) — e.g. 2026-09-17T17:17:32Z
• terminal (string/null) — null in every sample row
• pages_read (integer/null) — null in every sample row
• raw_seen (integer/null) — null in every sample row
• duplicates (integer/null) — null in every sample row
• unique_found (integer/null) — null in every sample row
• reported_total (integer/null) — null in every sample row
• delivered (integer/null) — null in every sample row

What you get

One record per unique 510(k) clearance:

• k_number — the FDA clearance number (e.g. K123456)
• applicant — the submitting company
• device_name — the cleared device
• product_code — the FDA three-letter product code
• decision_date — clearance decision date (ISO YYYY-MM-DD)
• decision_type / decision_code — the FDA decision description and code
• clearance_type — e.g. Traditional, Special, Abbreviated
• advisory_committee — the FDA review panel
• applicant_location — city, state, country as filed
• date_received — submission received date
• predicate_k_number — always null: the openFDA 510(k) dataset does not publish predicate device numbers, so this is carried as an honest absence, never inferred
• source, source_url, observed_at

Every run also writes a RUN_RECEIPT record to its key-value store with the source checks it made and the counts it charged — diagnostics never land in the paid dataset.

⚙️ Sample inputs

1. Quick start — the Store example (this is what the sample above came from)

{
  "maxRecords": 10,
  "pageLimit": 1
}

The sample run charged exactly: 1 × $0.02 apify-actor-start + 10 × $0.05 device_clearance = $0.52 on the Free tier — every delivered row was billed.

2. A smaller, narrowed run

{
  "maxRecords": 5,
  "pageLimit": 1
}

Caps the run at 5 rows — about $0.27 on the Free tier ($0.02 start + 5 × $0.05).

3. A full-size run

{
  "maxRecords": 1000,
  "pageLimit": 1
}

Up to 1000 rows (the schema default for maxRecords) — about $50.02 on the Free tier ($0.02 start + 1000 × $0.05) if the source has that many.

🧾 JSON sample record

One real record from run G9h4MhnmezGFr9HGD, exactly as it lands in the dataset (emails masked, long text shortened):

{
  "record_type": "device_clearance",
  "k_number": "K261131",
  "applicant": "Shenzhen Osto Medical Technology Co.,Ltd",
  "device_name": "Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; ",
  "product_code": "NUH",
  "decision_date": "2026-09-06",
  "decision_code": "SESE",
  "decision_type": "Substantially Equivalent",
  "clearance_type": "Traditional",
  "advisory_committee": "Neurology",
  "expedited_review": null,
  "third_party_review": "N",
  "statement_or_summary": "Statement",
  "applicant_location": "Shenzhen, CN",
  "date_received": "2026-04-06",
  "predicate_k_number": null,
  "source": "openfda-device-510k",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261131",
  "observed_at": "2026-09-17T17:17:32Z"
}

🔧 How it works

Source. The actor reads api.fda.gov, www.accessdata.fda.gov — endpoints: https://api.fda.gov/device/510k.json, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Public pages and feeds only; nothing behind a login.

Transport. Plain HTTPS from the Apify platform, no proxy.

Terminal states. A run ends NORMAL, CAPPED (your cap was reached), PARTIAL (something was withheld and the message says what), GENUINE_EMPTY (the source was read and truly had nothing in scope) or BLOCKED (the source refused or changed shape — the run FAILS loud and bills nothing). A zero-row run is never reported as a silent success.

Charging. Each device clearance is charged at the moment it is pushed (device_clearance); a row that fails to charge is not delivered, so the dataset count always equals the charged count.

Filtering

Bound your run by applicant, productCode, and a decisionDateFrom/decisionDateTo window. maxRecords caps the number of records delivered (a buyer-requested bound on the count, never a block). A filtered query that genuinely matches nothing succeeds and bills nothing.

How it behaves

The actor paginates the openFDA API newest-first, honouring the rate limit (~240 requests/minute) with a self-throttle. A source outage or a change in the API's response shape stops the run loudly and charges nothing — an empty result is never delivered as a success. A valid filtered query with no matches is a genuine empty result: it succeeds and bills nothing.

Data notes

This data comes directly from openFDA. Per the FDA's own disclaimer, do not rely on openFDA to make decisions regarding medical care; fields are carried as published and are not independently verified. This actor reports only what the FDA publishes.

What is not done. No login, no cookie or CAPTCHA bypass, no private or personal-account data, no browser automation.

💰 Pricing example

Event	Free	Bronze	Silver	Gold
Actor Start (apify-actor-start)	$0.02	$0.02	$0.02	$0.02
Device Clearance (device_clearance)	$0.05	$0.04	$0.04	$0.03

Worked at the live Free-tier price:

• 8 device clearances: $0.02 start + 8 × $0.05 = $0.42
• 25 device clearances: $0.02 start + 25 × $0.05 = $1.27
• 1000 device clearances: $0.02 start + 1000 × $0.05 = $50.02

A run that delivers zero rows charges the $0.02 start fee only. A BLOCKED run (source refused) fails loud and charges no value event. The start fee is charged once per GB of run memory; the default run memory is 1024 MB.

Yield on the sample run: CAPPED: delivered 10 of at least 11 unique clearances (maxRecords=10) — a buyer-requested bound, not an outage. read 11 page(s), 0 duplicate K-numbers collapsed. device_clearance billable=10. maxRecords is a hard ceiling on what is delivered and billed, never a target.

⚖️ Legal & ToS

This actor reads public, logged-out pages and feeds published by api.fda.gov, www.accessdata.fda.gov. It collects only what the source publishes to any visitor, identifies itself, and does not access accounts, private data or anything behind authentication. Use the output in line with the source's terms and your local law; the intended use is B2B research and monitoring.

❓ FAQ

Q: Do I need an API key or a login?
A: No. The source (api.fda.gov, www.accessdata.fda.gov) is read logged-out; the input schema has no key field and the actor carries no secrets.

Q: Why did my run return 0 rows?
A: Read the run's status message. GENUINE_EMPTY means the source was read and had nothing in scope for your input; BLOCKED means the source refused and the run failed without billing a value event — retry later or narrow the input. A zero-row run bills the start fee only.

Q: How many rows can one run return?
A: Up to maxRecords (default 1000). Raise the cap for a bigger run; you pay per delivered row.

Q: How fresh is the data?
A: Every run reads the source live at run time; nothing is cached between runs. Put it on a schedule for a continuous feed.

Q: What formats can I export?
A: The dataset downloads as JSON, CSV, Excel, XML or RSS from the run's Dataset tab or the Apify API, and any run can push to a webhook or integration.

Q: How is this different from the other product safety and approvals watches actors?
A: Same output shape and billing model; this one covers api.fda.gov, www.accessdata.fda.gov. The siblings under Related Actors cover the other sources or slices — run several on one schedule for a combined feed.

Q: Are there rate limits?
A: The actor paces itself against the source; there is no per-buyer limit beyond your Apify plan's concurrency.

🆘 Troubleshooting

• Run FAILED with BLOCKED → the source refused the request or changed its page shape → nothing was billed beyond the start fee; retry after a while, and if it persists open an Issue with the run id.
• Status says CAPPED → your cap (maxRecords) was reached → raise it for a bigger run.
• Input validation error on start → a field is outside the schema's allowed values → start from the Quick start block and change one field at a time.
• Run TIMED-OUT → a very wide request on a slow day → raise the run timeout in Run options or narrow the input; what was delivered before the timeout is still in the dataset.

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