{"uid":"cap_mvTx2xWJsQEJkO-NQXOTB","slug":"clearcheck-fda-device-clearance-recall-lookup-7bf3e91b","name":"ClearCheck — FDA Device Clearance & Recall Lookup","description":"Is this medical device FDA-cleared, and has it been recalled? 510(k) clearances joined to recall enforcement.","url":"https://loonie-toll.onrender.com/device","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":[],"properties":{"firm":{"type":"string","description":"Manufacturer or applicant name"},"limit":{"type":"integer","description":"Max records per section, default 8"},"device":{"type":"string","description":"Device name or type, e.g. 'infusion 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up FDA 510(k) clearances and recall enforcement records for a medical device or manufacturer, returning a combined safety verdict.","exampleAgentPrompt":"Can you check whether infusion pumps made by Baxter have FDA 510(k) clearance and whether there are any open recalls against them — show me up to 10 records per section?","exampleUseCases":[{"title":"Pre-purchase device safety check","prompt":"Before we buy these pulse oximeters from Nonin Medical, can you check if they're FDA 510(k) cleared and whether there are any active recalls I should know about?"},{"title":"Hospital procurement compliance review","prompt":"Pull the FDA clearance and recall history for Abbott's glucose monitoring devices — I need to know the verdict and any open recalls before we renew our supply contract."},{"title":"Patient safety incident investigation","prompt":"We had an incident with an infusion pump and I need to know if there are any FDA recalls related to infusion pumps, including the reason and root cause for each one."}],"resultDescription":"Returns a structured response including: a verdict string summarizing device safety status, arrays of 510(k) clearance records (k-number, applicant, device name, decision date, product code), recall records (recall number, product, recalling firm, reason, root cause, status, quantities, distribution, dates), counts of total clearances, total recalls and open recalls, recall reason strings, data source attribution, retrieval timestamp, and a regulatory disclaimer.","failureModes":["No matching device or firm found — returns empty arrays with zero counts","Ambiguous device name matches too many records — results may be broad; use firm parameter to narrow","FDA openFDA API downtime — upstream data unavailable","Invalid query parameters — 400-level error","Rate limiting or payment failure — 402 response requiring x402 payment"],"whenToPreferThis":"Use this endpoint when you need a single combined view of both FDA 510(k) clearance status AND recall enforcement for a medical device or manufacturer. It saves the step of querying FDA openFDA clearance and enforcement endpoints separately and delivers a pre-joined verdict. Prefer it over raw FDA API calls when you need a quick go/no-go safety assessment rather than deep regulatory dossier research.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-09-14T12:47:43.154Z","isFirstParty":false}