Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Biometric Products, Inc. — Predicate Candidate Screening

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

295 daysmedian FDA review time
349 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933021MODEL T131 MEMORY TRANSMITTERBiometric Products, Inc.1994-06-063490
K863376MODEL MC-1 SURGICAL VIDEO CAMERABiometric Products, Inc.1986-10-02290
K842435MODEL T 101 CLINICAL TRANSMITTERBiometric Products, Inc.1985-05-163300
K840032TELEPHONE RECEIVERS R101 R111Biometric Products, Inc.1984-10-262950
K832951MEMORY LOOP TRANSMITTER #121Biometric Products, Inc.1984-02-171680

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