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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Hirata Sangyo Co. USA, Inc. · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time
103 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K864106SR-MODEL 230 (MODIFICATION)Hirata Sangyo Co. USA, Inc.1986-11-19290
K842289SR- MODEL 230Hirata Sangyo Co. USA, Inc.1984-07-25470
K833541SURGICAL INSTRUMENTHirata Sangyo Co. USA, Inc.1983-11-28620
K833542SURGICAL INSTRUMENTHirata Sangyo Co. USA, Inc.1983-11-28620
K832686MULTIPLE MANUAL SURGICAL INSTRUMENTSHirata Sangyo Co. USA, Inc.1983-10-14730
K831583GP-303Hirata Sangyo Co. USA, Inc.1983-07-19630
K821989NON-STETHO 7, UM-15TPHirata Sangyo Co. USA, Inc.1982-10-181030
K822571SYRINGE PUMPHirata Sangyo Co. USA, Inc.1982-10-08450

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda