FDA applicant
Biosafety Systems, Inc.
FDA records 8 decisions for Biosafety Systems, Inc. (San Diego, CA) from 1990 to 1995: 8 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biosafety Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biosafety Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biosafety Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report