{"uid":"cap_FN8dsbm2vekQItJW0ffl3","slug":"sitecheck-health-travel-fda-510-k-premarket-notifications-168b3425","name":"SiteCheck Health & Travel – FDA 510(k) Premarket Notifications","description":"FDA 510(k) premarket notifications (openFDA): K-number, device name, applicant, decision (e.g. Substantially Equivalent), decision and received dates, product code and advisory committee. Up to 10 per call.","url":"https://api.healthtravel-api.workers.dev/api/health/fda-medical-device-510k?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","required":["q"],"properties":{"q":{"type":"string","description":"Device name words, letters, digits and spaces, 2 to 60 characters"},"max":{"type":"string","description":"How many clearances, 1 to 10 (default 5)"}}}},"additionalProperties":false},"output":{"type":"object","required":["type"],"properties":{"type":{"type":"string"},"example":{"type":"object"}}}}},"responseSchema":null,"example":null,"exampleRequest":null,"tags":["x402"],"displayCostAmount":"0.002","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":"$0.002/call","primary":{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.002","per":"call","confidence":"exact"},"accepted":[{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.002","per":"call","confidence":"exact"}]},"paymentMethods":[{"uid":"pm_jjTlZb1StjaYsBjUUoZ5t","protocol":"x402","methodType":"crypto","chain":"base","mode":"charge","costAmount":"0.002","costPer":"request","priority":0,"asset":"0x833589fCD6eDb6E08f4c7C32D4f71b54bdA02913","unit":"request","depositMicros":null,"planRef":null}],"brandName":null,"brandSlug":null,"brandBaseUrl":null,"brandDocsUrl":null,"whatItDoes":"Searches FDA 510(k) premarket notification clearance records by device name, returning K-number, applicant, decision, dates, and product code for up to 10 results.","exampleAgentPrompt":"Can you look up the FDA 510(k) clearance records for 'glucose monitor' and show me up to 8 results — I need the K-number, applicant, and decision for each?","exampleUseCases":[{"title":"Verify device FDA clearance status","prompt":"I need to check whether the 'pulse oximeter' has FDA 510(k) clearance — can you search the openFDA database and give me the K-number, applicant, decision, and dates for the top 5 results?"},{"title":"Research competitor device filings","prompt":"Look up FDA 510(k) premarket notifications for 'bone screw' and return up to 10 results — I want to see who the applicants are and what decisions they received."},{"title":"Regulatory due diligence on a device","prompt":"I'm doing due diligence on a company — can you find FDA 510(k) clearance records for 'infusion pump', get 10 results, and tell me the K-numbers, applicants, decisions, and decision dates?"}],"resultDescription":"Returns up to 10 FDA 510(k) premarket notification records from openFDA, each containing: K-number, device name, applicant name, decision (e.g. Substantially Equivalent), decision date, received date, product code, and advisory committee classification.","failureModes":["Query string too short (under 2 chars) or too long (over 60 chars) returns validation error","No matching 510(k) records found for the search term returns empty result set","openFDA upstream service unavailable causes timeout or 5xx error","Invalid 'max' value outside 1–10 range may be rejected or defaulted","Rate limiting or payment failure due to x402 protocol issues"],"whenToPreferThis":"Use this endpoint when you need to search FDA 510(k) premarket notification clearance records by device name. It is ideal for regulatory research, compliance verification, due diligence, and competitive intelligence on cleared medical devices. Prefer this over FDA Purple Book (which covers biologics) or AccessGUDID (which looks up by Device Identifier barcode number) when you have a device name and need clearance history and K-numbers.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-10-29T00:33:48.812Z","isFirstParty":false,"canonicalSlug":"sitecheck-health-travel-fda-510-k-premarket-notifications-168b3425"}