Atlas FDA

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

Bioclinical Laboratory Services, Inc. — Predicate Candidate Screening

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

75 daysmedian FDA review time
112 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870451SKIN GRAFT PRESERVATION MEDIUM (TISSUE)Bioclinical Laboratory Services, Inc.1987-05-261120
K870249MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06750
K870250MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06750
K870251CHONDROITIN SULFATE CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06750
K864396LYMPHOCYTE MAINTENANCE MEDIUMBioclinical Laboratory Services, Inc.1987-02-02880
K864740BONE MARROW COLLECTION MEDIUMBioclinical Laboratory Services, Inc.1987-01-05320

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