{"uid":"cap_yXVaF6-PxQUFIAle0KlK7","slug":"fda-510-k-device-clearances-4cd6c8da","name":"FDA 510(k) Device Clearances","description":"FDA 510(k) clearances for medical devices: which devices were cleared to market, the applicant, the decision date, product code, device class, regulation number and advisory committee, plus a clearance-per-year breakdown. Search by device name, applicant company or K-number. Pairs with the adverse-events and enforcement endpoints for full medtech diligence.","url":"https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances?utm_source=zero.xyz","method":"GET","headers":{},"bodySchema":{"type":"object","$schema":"https://json-schema.org/draft/2020-12/schema","required":["input"],"properties":{"input":{"type":"object","required":["type","method"],"properties":{"type":{"type":"string","const":"http"},"method":{"enum":["GET"],"type":"string"},"queryParams":{"type":"object","properties":{"to":{"type":"string","examples":["2026-08-24"],"description":"Decision on or before, ISO date."},"from":{"type":"string","examples":["2024-01-01"],"description":"Decision on or after, ISO date."},"limit":{"type":"integer","examples":[25],"description":"Max clearances, 1-100. Default 25."},"device":{"type":"string","examples":["catheter"],"description":"Device name to search."},"kNumber":{"type":"string","examples":["K123456"],"description":"Exact 510(k) number, e.g. K123456."},"applicant":{"type":"string","examples":["Medtronic"],"description":"Applicant company name."}}}},"additionalProperties":false},"output":{"type":"object","required":["type"],"properties":{"type":{"type":"string"},"example":{"type":"object"}}}}},"responseSchema":null,"example":null,"exampleRequest":null,"tags":["x402"],"displayCostAmount":"0.02","displayCostAsset":"USDC","priceDynamic":false,"priceHint":null,"priceStatus":"priced","priceSource":"probe","requiresHandshake":false,"reviewCount":0,"rating":{"score":"0.00","successRate":"0.00","reviews":0,"stars":null,"state":"unrated"},"availabilityStatus":"unknown","priceObserved":null,"sessionDeposit":null,"pricing":{"kind":"static","summary":"$0.02/call","primary":{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.02","per":"call","confidence":"exact"},"accepted":[{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.02","per":"call","confidence":"exact"}]},"paymentMethods":[{"uid":"pm_7ALhS-XwBtwoh2XQm0-WQ","protocol":"x402","methodType":"crypto","chain":"base","mode":"charge","costAmount":"0.02","costPer":"request","priority":0,"asset":"0x833589fCD6eDb6E08f4c7C32D4f71b54bdA02913","unit":"request","depositMicros":null,"planRef":null}],"brandName":null,"brandSlug":null,"brandBaseUrl":null,"brandDocsUrl":null,"whatItDoes":"Retrieves FDA 510(k) medical device clearance records including device name, applicant, decision date, product code, device class, regulation number, and advisory committee, with clearances-per-year breakdown.","exampleAgentPrompt":"Can you look up FDA 510(k) clearances for catheter devices from Medtronic, show me up to 50 results, and include decisions made between 2020-01-01 and 2024-12-31?","exampleUseCases":[{"title":"Medtech due diligence on a device maker","prompt":"I'm doing diligence on a startup that makes cardiac monitors — can you pull their FDA 510(k) clearances from Becton Dickinson, limit to 25, and tell me what device classes and product codes they've been cleared for?"},{"title":"Verify clearance status for a specific device","prompt":"Can you look up FDA 510(k) clearance K213456 and tell me the applicant, the decision date, and what advisory committee reviewed it?"},{"title":"Track device clearance trends over time","prompt":"Show me all FDA 510(k) clearances for glucose monitoring devices between 2018-01-01 and 2023-12-31, up to 100 results, so I can see how many were cleared each year."}],"resultDescription":"Returns a list of FDA 510(k) clearance records, each containing the device name, applicant company, decision date, K-number, product code, device class, regulation number, and advisory committee. Also includes a clearances-per-year breakdown for trend analysis. Results are filterable by device name keyword, applicant, K-number, and date range.","failureModes":["No records found for an obscure or misspelled device name — returns empty result set","K-number format mismatch (e.g. missing leading K) returns no results","Date range too narrow returns empty list","limit parameter out of range (not 1-100) may return validation error","Applicant name variation (abbreviation vs full legal name) may miss records"],"whenToPreferThis":"Use this endpoint when you need structured, searchable FDA 510(k) clearance data for medical devices — especially for medtech due diligence, regulatory verification, or competitive research. Pairs with the FDA adverse-events and enforcement endpoints on the same provider for comprehensive regulatory picture. Prefer over manual FDA database searches when programmatic, filterable access by device name, company, K-number, or date range is needed.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-10-13T00:34:41.056Z","isFirstParty":false,"canonicalSlug":"fda-510-k-device-clearances-4cd6c8da"}