FDA 510(k) Database Search & API: Clearances

This FDA 510(k) database search finds premarket notification clearances by device name, company, product code, K number or decision date, and returns them as clean rows you can filter and export. Each clearance comes with its official FDA classification (device class, regulation number, classification definition, implant flag), a link to the 510(k) summary PDF and the FDA database page, and a plain-language product category. Describe your own device and every clearance also gets a predicate hint: is this cleared device a plausible predicate for yours, judged only from official FDA fields.

What does FDA 510(k) Search do?

• Search the 510(k) database with several filters at once, for example all pulse oximeters cleared since 2025, or everything Medtronic got cleared this quarter.
• Look up K numbers (and De Novo numbers), many in one run.
• Join the classification for each product code, so you see class, regulation and definition next to every clearance without a second search.
• Find predicate candidates. Give your device's intended use and product code. The Actor lists clearances under that code and ranks them as strong, possible or unlikely predicate candidates.

What data you get

Field	What it is
kNumber	510(k) number (K123456) or De Novo number (DEN123456)
deviceName, applicant	Device name and company as submitted
decisionDate, decision, decisionCode	FDA decision, for example Substantially equivalent (SESE)
dateReceived, clearanceType	Submission date; Traditional, Special or Abbreviated
productCode, classificationName, deviceClass, regulationNumber	Official classification
medicalSpecialty, reviewPanel	Medical specialty and advisory committee
definition, implant, lifeSustaining	From the classification record
clearancesWithSameProductCode	How many 510(k)s exist under the same product code
summaryOrStatement, summaryPdfUrl	Whether a summary was published, and its PDF on accessdata.fda.gov
thirdPartyReview, expeditedReview	Review flags
applicantAddress	Company address as filed with the 510(k)
productCategory	Plain-language category such as Patient monitoring or Medical software, with confidence
predicateHint	For your own device: strong, possible or unlikely, with probability
fdaDatabaseUrl	The clearance page in the official FDA 510(k) database

The contact person named in a submission is left out on purpose.

How to search the FDA 510(k) database step by step

1. Add one or more searches, for example {"deviceName": "pulse oximeter", "decisionDateFrom": "2025-01-01"}.
2. Or paste K numbers, one per line.
3. Optional: describe your device under Your device to get predicate hints.
4. Click Start. The sample input finishes in about 15 seconds.
5. Export to JSON, CSV or Excel, or read the dataset through the API.

All fields in one search must match. To search for two companies, add two searches.

How do I find predicate devices for my 510(k)?

Put your device into Your device:

{"description": "Fingertip pulse oximeter for spot-check SpO2 and pulse rate in adults, for home use", "productCode": "DQA"}

The Actor searches all clearances under DQA (newest first) and asks one fixed question per clearance: could this be a reasonable predicate, meaning the same kind of device with the same intended use and similar technology? The answer uses only official fields: device name, product code, classification name and definition, class, regulation and decision date. Code turns the probability into the hint:

Hint	Probability
strong	0.7 or more
possible	0.4 to 0.7
unlikely	below 0.4

In the sample run on 29 October 2026, fingertip oximeters came back strong (0.83 to 0.92), an oxygen ring possible (0.64), and reusable SpO2 clip sensors, which are accessories, unlikely (0.28). The hint narrows your shortlist. It is not a regulatory opinion: read the summaries and check the intended use and technological characteristics yourself.

How much does it cost?

Pay per event:

Event	Price	When
Clearance record	$0.002	Each 510(k) clearance returned, with classification and product category
Predicate hint	$0.005	Each clearance compared with your own device
Actor start	$0.00005	Once per run

Not charged: K numbers that are not found, invalid numbers, and searches with no match (each gets one free row). Example: 500 clearances cost $1. A predicate search over the 200 newest clearances of one product code costs $1.40.

Input

{
  "searches": [
    {"deviceName": "pulse oximeter", "decisionDateFrom": "2025-01-01"},
    {"applicant": "Medtronic", "decisionDateFrom": "2026-07-01"}
  ],
  "kNumbers": ["K163345"],
  "myDevice": {"description": "Fingertip pulse oximeter for spot-check SpO2 and pulse rate in adults, for home use", "productCode": "DQA"},
  "productCategory": true,
  "newestFirst": true,
  "maxResultsPerSearch": 50
}

Search fields: deviceName, applicant, productCode, kNumber, decisionDateFrom, decisionDateTo, clearanceType, advisoryCommittee, country.

Output

{
  "kNumber": "K163345",
  "deviceName": "TVC Imaging System, TVC Catheter",
  "applicant": "Infraredx, Inc.",
  "decisionDate": "2017-06-21",
  "decision": "Substantially equivalent",
  "dateReceived": "2016-11-29",
  "clearanceType": "Traditional",
  "productCode": "OGZ",
  "classificationName": "Catheter, Intravascular, Plaque Morphology Evaluation",
  "deviceClass": "2",
  "regulationNumber": "870.1200",
  "medicalSpecialty": "Cardiovascular",
  "definition": "Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics.  For examination of morphologic features of coronary or peripheral artery lesions or plaques.",
  "implant": false,
  "clearancesWithSameProductCode": 9,
  "summaryPdfUrl": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163345.pdf",
  "fdaDatabaseUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163345",
  "productCategory": {"key": "cardiovascular", "label": "Heart and blood vessel devices", "confidence": 0.98},
  "summary": "K163345: TVC Imaging System, TVC Catheter by Infraredx, Inc., Substantially equivalent on 2017-06-21, product code OGZ (class 2)."
}

Use cases

• Regulatory affairs: shortlist predicate devices and pull their summaries for a new 510(k).
• Competitive intelligence: track every clearance of a competitor or a product code.
• Medtech sales and BD: find companies that just cleared a device in your field.
• Investors and analysts: count clearances per company, product code or panel over time.
• Distributors and hospitals: confirm that a device on offer has a 510(k) and see its class.

Why not the openFDA API or the FDA website directly?

The FDA website searches one form at a time. The openFDA API is free and this Actor uses it, but the raw API needs query syntax, returns at most 1,000 rows per call, and keeps the classification in a separate endpoint. This Actor runs many searches in one go, pages for you, joins the classification for each product code, adds the summary PDF link, and adds the product category and predicate hints.

FAQ

Is this official FDA data?

Yes. Rows come from the openFDA device 510(k) and device classification endpoints, which FDA publishes as public data with a CC0 dedication. FDA notes that openFDA data is not validated for clinical decisions; check the official FDA database page linked in each row before you rely on it.

Data provided by the U.S. Food and Drug Administration (open.fda.gov). Not affiliated with or endorsed by FDA.

Can I use 510(k) data commercially?

FDA publishes openFDA data as public domain with a CC0 1.0 dedication, which allows commercial reuse. Most applicants are companies, but some submitters are individuals or consultants, so an applicant name and address can be personal data; handle it under the privacy rules that apply to you. The contact person listed in submissions is left out. You are responsible for your own use; this README is not legal advice.

Does the FDA 510(k) database have an API?

Yes, openFDA. This Actor is a layer on it with classification join, PDF links and predicate hints. See "Why not the openFDA API or the FDA website directly?" above.

How much does it cost?

$0.002 per clearance and $0.005 per predicate hint. 1,000 clearances cost $2.

Does it read the 510(k) summary PDFs?

No. Predicate hints use only the structured official fields. The summary PDF link is in each row so you can read the predicate device and the comparison table yourself.

How current is the data?

openFDA updates the 510(k) data regularly, and each run reads the live openFDA data. The date of openFDA's last update is part of every openFDA response.

Can I use it from Python, n8n, Make or an AI agent (MCP)?

Yes. Every Apify Actor has a REST API, Python and JavaScript clients, and integrations with n8n, Make, Zapier and MCP-capable AI agents. See the API tab.

Can I get alerts for new clearances?

Yes. Save a search with decisionDateFrom as an Actor task and schedule it weekly.

Do I need an openFDA key?

openFDA asks API users to get a free API key. Without a key, openFDA allows 240 requests per minute and 1,000 requests per day per IP address, and the Actor runs on shared cloud addresses. For regular or larger use, add your own free openFDA key in the input (with a key the daily limit is 120,000). Either way the Actor stays below 240 requests per minute and stops after a fixed number of requests per run (900 without a key, 5,000 with a key).

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