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Two datasets cover FDA 510(k) premarket notifications:
  • device510k: the structured clearance records — device name and class, product code, applicant, decision code and date, advisory committee, and regulation number.
  • device510k-summaries: the 510(k) summary PDFs behind those clearances, with per-page extracted text, so you can search the actual submission content, not just the metadata.
Each dataset requires its own Evidence scope. See the Evidence overview for how scopes work.

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Search clearances

Each item in results includes title, statementOrSummary, summaryText, kNumbersMentioned, a device object (kNumber, tradeName, deviceName, deviceClass, productCode, clearanceType, regulationNumber, medicalSpecialtyDescription), a decision object (decisionCode, decisionDescription, decisionDate, advisoryCommittee, expeditedReviewFlag), and applicantInformation. s accepts _relevance (default), device.device_class, device.date_received, and decision.decision_date.

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Search summary PDFs

Results are documents with filename and attachments; each attachment carries pages with extracted text (content), page counts, file metadata, and ontology tags/categories. Use this when the question is about what a submission actually says — predicate device claims, testing summaries, intended use — rather than the clearance metadata.

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Single record

GET /api_partner/evidence/device510k/{device_id} and GET /api_partner/evidence/device510k-summaries/{item_id} return one full record each.

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Common uses

  • Predicate research: search summaries for a device type to find the predicate chains competitors cite; kNumbersMentioned on clearance records links related submissions.
  • Regulatory watch: sort clearances by decision.decision_date and filter by product code or advisory committee to monitor a device category.
  • Full safety picture: combine with MAUDE adverse-event reports for post-market signals on the same devices.