FDA 510(k) New Clearance Leads | Business Leads

Find the companies that just got a medical device cleared by the FDA. This tool reads the official openFDA 510(k) database and gives you one clean row per decision, newest first: the applicant company and its address, the device name, FDA product code, device class, review specialty, clearance type, decision date and a link to FDA's own 510(k) page. A fresh clearance is a trigger event: the company is about to launch, hire, source, certify, market and sell.

• 🩺 Trigger leads: companies with a new substantially equivalent (cleared) decision. De Novo grants and other decisions are optional.
• 🎯 Filters: decision date range (default: last 30 days), applicant US state or country, FDA product code, specialty, device class, clearance type, applicant name, device name, third-party review.
• 🔒 Firm-level only: the applicant company name and address as filed with FDA. The openFDA contact-person field is never read, so there are no personal names, phones or emails in the output.
• 💲 $3.00 per 1,000 clearances ($0.003 per row). No start fee. Empty and failed runs are free.

Data source: Data provided by the U.S. Food and Drug Administration (https://open.fda.gov), openFDA device 510(k) endpoint (api.fda.gov/device/510k.json). openFDA data is public domain under a Creative Commons CC0 1.0 dedication (open.fda.gov/terms). Every row has a source credit, a sourceUrl link to FDA's 510(k) database page and an openFdaApiUrl link to the API record.

Disclaimer: Not affiliated with, endorsed by or sponsored by the U.S. FDA. A 510(k) clearance means FDA found a device substantially equivalent to an existing device; it is not FDA approval of the company or an endorsement. openFDA data is unvalidated. Confirm details on FDA's own page (sourceUrl) before you rely on them.

What does it do?

1. It turns your filters into filtered, paged queries to the official openFDA API (no API key needed), up to 1,000 decisions per request, sorted by decision date, newest first.
2. It builds one row per K number (or DEN number for De Novo), de-duplicated, with the applicant's name and address and the device facts.
3. It stops as soon as it has Max results rows, or when it reaches the maximum cost you set for the run.

In local tests on 2026-11-03, the default input (substantially equivalent decisions of the last 30 days, up to 100) saved 100 clearances in 0.9 to 1.0 seconds of Actor time (1 openFDA request, about 4 seconds wall time including startup) and peaked at 73 to 74 MB of memory. At that moment 162 decisions matched. A maximum-size run of 50,000 decisions took 78 seconds (50 requests) and peaked at 192 MB.

Who is it for?

• Sales and business development teams at contract manufacturers, sterilization and testing labs, packaging, component and software vendors: reach companies right after a clearance, while launch budgets are open.
• Regulatory and quality consultancies and law firms: find newly cleared companies that now face post-market obligations.
• Medical device marketers, distributors and recruiters: spot launches by specialty, product code or state.
• Investors and market researchers: track clearance volume by company, specialty and country.

Input

Field	Default	What it does
recentDays	30	Used when decisionDateFrom is empty: decisions in the last N days.
decisionDateFrom / decisionDateTo	empty	Decision date range, YYYY-MM-DD. Overrides recentDays. decisionDateTo empty = today.
decisions	["substantiallyEquivalent"]	Any of substantiallyEquivalent (cleared), deNovoGranted, otherSubstantiallyEquivalent (some indications, tracking, inspection). All three = no decision filter.
states	all	Applicant US states: CA, tx, Minnesota...
countries	all	Two-letter ISO country codes of the applicant: US, KR, DE, CN...
productCodes	all	Three-letter FDA product codes, e.g. QKQ, HRS.
advisoryCommittees	all	FDA review specialty, e.g. Orthopedic, Radiology, Cardiovascular.
deviceClasses	all	1, 2, 3, U (unclassified), N, F (HDE). A few decisions have no class on file in openFDA, so a class filter leaves those out.
clearanceTypes	all	Traditional, Special, Abbreviated, Direct, Dual Track, Post-NSE.
applicantName	empty	Whole words from the applicant name, e.g. Medtronic or Globus Medical.
deviceNameKeyword	empty	Whole words from the device trade name, e.g. software.
thirdPartyReviewOnly	false	Only decisions reviewed by an FDA-accredited third party.
maxResults	100	Stop after this many clearances (up to 50,000), newest first.
maxApiCalls	100	Safety cap on openFDA requests per run (each reads up to 1,000 decisions).
openFdaApiKey	empty	Optional, secret. Your own free openFDA key, only if you need a higher daily limit.

{
  "recentDays": 60,
  "states": ["CA", "MA"],
  "advisoryCommittees": ["Orthopedic", "Cardiovascular"],
  "maxResults": 500
}

All filters are combined with AND. Values inside one filter are combined with OR.

What's in each row?

Area	Fields
Company	companyName (the applicant as filed with FDA), street, city, state (US only), zipCode, country (2-letter code), address (one line)
Clearance	kNumber, submissionType (510(k) or De Novo), decisionDate, dateReceived, daysToDecision, decisionCode, decisionDescription (as listed by FDA, empty when FDA lists "Unknown"), decisionCategory, clearanceType, thirdParty, summaryType
Device	deviceName (trade name), deviceClassificationName (FDA classification name), productCode, regulationNumber, deviceClass, medicalSpecialty, advisoryCommittee, advisoryCommitteeCode
Links and credit	sourceUrl (FDA's 510(k) or De Novo database page), openFdaApiUrl (the API record), source, disclaimer, dataLastUpdated (openFDA's last update), retrievedAt

There are no person names, emails or phone numbers in the output. The openFDA contact field is never read, and a scrub strips email addresses and phone-like numbers from company names and address lines. A run summary (filters, counts, openFDA requests, warnings) is saved as RUN_SUMMARY in the run's key-value store.

Output example

Real rows from a local run of the default input on 2026-11-03, unedited. A US applicant:

{
  "companyName": "Globus Medical, Inc.",
  "kNumber": "K262779",
  "submissionType": "510(k)",
  "deviceName": "ANTHEM™ Fracture System",
  "deviceClassificationName": "Plate, Fixation, Bone",
  "productCode": "HRS",
  "regulationNumber": "888.3030",
  "deviceClass": "Class II",
  "medicalSpecialty": "Orthopedic",
  "advisoryCommittee": "Orthopedic",
  "advisoryCommitteeCode": "OR",
  "clearanceType": "Traditional",
  "decisionDate": "2026-10-23",
  "dateReceived": "2026-08-05",
  "daysToDecision": 79,
  "decisionCode": "SESE",
  "decisionDescription": "Substantially Equivalent",
  "decisionCategory": "Substantially equivalent (510(k) clearance)",
  "thirdParty": false,
  "summaryType": "Summary",
  "street": "2560 General Armistead Ave.",
  "city": "Audubon",
  "state": "PA",
  "zipCode": "19403",
  "country": "US",
  "address": "2560 General Armistead Ave., Audubon, PA 19403, US",
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262779",
  "openFdaApiUrl": "https://api.fda.gov/device/510k.json?search=k_number%3A%22K262779%22&limit=1",
  "source": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov), openFDA device 510(k) dataset, public domain (CC0 1.0).",
  "disclaimer": "Not affiliated with, endorsed by or sponsored by the U.S. FDA. A 510(k) decision date and number come from openFDA and are unvalidated; confirm details on FDA's own 510(k) database page (sourceUrl). Company data is the applicant as filed with FDA, not a verified current address.",
  "dataLastUpdated": "2026-10-26",
  "retrievedAt": "2026-11-03T18:15:00Z"
}

A foreign applicant (no US state):

{
  "companyName": "Cascination AG",
  "kNumber": "K262080",
  "submissionType": "510(k)",
  "deviceName": "OTOPLAN",
  "deviceClassificationName": "Image Management Software For Planning Of Otologic And Neurotologic Procedures",
  "productCode": "QQE",
  "regulationNumber": "892.2050",
  "deviceClass": "Class II",
  "medicalSpecialty": "Radiology",
  "advisoryCommittee": "Radiology",
  "advisoryCommitteeCode": "RA",
  "clearanceType": "Traditional",
  "decisionDate": "2026-10-23",
  "dateReceived": "2026-06-22",
  "daysToDecision": 123,
  "decisionCode": "SESE",
  "decisionDescription": "Substantially Equivalent",
  "decisionCategory": "Substantially equivalent (510(k) clearance)",
  "thirdParty": false,
  "summaryType": "Summary",
  "street": "Steigerhubelstrasse 3",
  "city": "Bern",
  "state": null,
  "zipCode": "3008",
  "country": "CH",
  "address": "Steigerhubelstrasse 3, Bern, 3008, CH",
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262080",
  "openFdaApiUrl": "https://api.fda.gov/device/510k.json?search=k_number%3A%22K262080%22&limit=1",
  "source": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov), openFDA device 510(k) dataset, public domain (CC0 1.0).",
  "disclaimer": "Not affiliated with, endorsed by or sponsored by the U.S. FDA. A 510(k) decision date and number come from openFDA and are unvalidated; confirm details on FDA's own 510(k) database page (sourceUrl). Company data is the applicant as filed with FDA, not a verified current address.",
  "dataLastUpdated": "2026-10-26",
  "retrievedAt": "2026-11-03T18:15:00Z"
}

Pricing

$3.00 per 1,000 clearances. One clearance event ($0.003) per saved row. There's no start fee and no run fee. Runs that find nothing, and runs that fail because openFDA can't be reached, are free. If you set a maximum cost per run, the Actor stops cleanly before it goes over.

Good to know

• Freshness: openFDA updates its 510(k) data about weekly and trails FDA's own database. On 2026-11-03 the data was last updated 2026-10-26 and the newest decision date was 2026-10-23, so "last 30 days" covered decisions up to Oct 23. dataLastUpdated shows the openFDA update date on every row.
• Cleared, not approved. 510(k) clearance is not FDA approval, and De Novo is a separate path (granted, not cleared). Use decisionCategory to tell them apart.
• Company data is as filed. Applicant names and addresses are exactly as on the FDA record. A few small applicants may be named after a person; that's the business name on file with FDA. For US applicants state is the two-letter code; for foreign ones it's empty.
• FDA links use FDA's public database page pattern for each K number. The Actor never fetches accessdata.fda.gov.
• Fair use of openFDA: keyless access allows 240 requests per minute and 1,000 per day per IP address. The default run makes 1 request. If openFDA ever refuses a run, the Actor stops quickly and charges nothing. It doesn't use proxies.
• Use the data in line with your own legal and marketing obligations, such as CAN-SPAM, the TCPA and state privacy laws. This tool gives you companies and addresses, not contact people.

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FAQ

Is this an official FDA list? No. It's an independent tool built on FDA's public openFDA API. It is not affiliated with or endorsed by the FDA.

Does it include contact people? No, by design. openFDA lists a contact person for each submission; this tool never reads that field. You get the company, its address, the device and the decision.

What's the difference from the FDA Medical Device Establishment Leads tool? That one lists FDA-registered device establishments (who makes, sterilizes or relabels devices). This one lists new 510(k) decisions: companies that just got a specific device cleared.

Do I need an API key? No. The openFDA API is keyless for this volume. You can add your own free key for heavier use.

Is it legal to use this data? openFDA publishes this data as public domain (CC0 1.0). Use the results in line with your own legal and compliance obligations.