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FDA 510k Medical Devices Clearance & Predicate Device Scraper

Try for free

Extract official FDA 510(k) premarket clearance decisions, device trade names, applicant sponsors, decision dates, and product codes.

Pricing

from $2.80 / 1,000 item scrapeds

Rating

0.0

(0)

Developer

LiteZero

Actor stats

Bookmarked

Total users

Monthly active users

4 days ago

Last modified

Key Features

Premarket Clearance: K-number identifier, decision date, and substantial equivalence rulings.
Applicant Intelligence: Sponsor manufacturing company and review advisory panel.
MedTech Competitive Monitoring: Track competitor submissions and newly cleared surgical, diagnostic, and therapeutic devices.

Sample Output

{
  "kNumber": "K240182",
  "deviceName": "Acuity BioSense Diagnostic Monitor",
  "applicant": "BioTech Medical Instruments Inc.",
  "decisionDate": "2024-03-15",
  "decisionDescription": "Substantially Equivalent (SESE)",
  "productCode": "DQA",
  "reviewAdvisoryCommittee": "Cardiovascular",
  "clearanceType": "Traditional",
  "dataSource": "OpenFDA 510(k) Clearances",
  "scrapedAt": "2026-10-13T13:30:00.000Z"
}

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