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

Hyclone Laboratories, Inc. — Predicate Candidate Screening

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

49 daysmedian FDA review time
58 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884654ALPHACALF SERUMHyclone Laboratories, Inc.1988-11-30230
K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone Laboratories, Inc.1988-04-04610
K880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.1988-04-01580
K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.1987-03-31220
K870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151Hyclone Laboratories, Inc.1987-03-24490
K870464CHARACTERIZED FETAL BOVINE SERUM #A-1115Hyclone Laboratories, Inc.1987-03-24490
K870468ADULT BOVINE SERUMHyclone Laboratories, Inc.1987-03-24490
K870463DEFINED FETAL BOVINE SERUM #A-1111Hyclone Laboratories, Inc.1987-03-24490
K870466DEFINED CALF BOVINE SERUM #A-2111Hyclone Laboratories, Inc.1987-03-24490
K8704656/40 FETAL BOVINE SERUM #A-1110Hyclone Laboratories, Inc.1987-03-24490
K870469DEFINED EQUINE SERUM #A-3311Hyclone Laboratories, Inc.1987-03-24490

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