510(k) Report

FDA applicant

Biosafety Systems, Inc.

San Diego, CA8 decisions1990–19950 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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.

FIG. 1 — Biosafety Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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