Atlas FDA

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

Biosafety Systems, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
177 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952274CHEMOGUARD, P2 HIRISKBiosafety Systems, Inc.1995-08-291060
K944514P2 NITRILE EXAM GLOVESBiosafety Systems, Inc.1994-11-28740
K944095P2 NITRILE EXAM GLOVESBiosafety Systems, Inc.1994-10-28670
K944142P2 EXAM GLOVESBiosafety Systems, Inc.1994-10-28640
K921313AEROSTARBiosafety Systems, Inc.1992-09-111770
K904130CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)Biosafety Systems, Inc.1990-10-10350
K901411CHEMOPLUS GLOVEBiosafety Systems, Inc.1990-06-07730
K900368P2/CHEMO PLUS GLOVESBiosafety Systems, Inc.1990-03-08410

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