510(k) Report

FDA applicant

Baldur Systems Corp.

Hayward, CA6 decisions1989–19980 recalls

FDA records 6 decisions for Baldur Systems Corp. (Hayward, CA) from 1989 to 1998: 6 510(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 Baldur Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baldur Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Baldur Systems Corp.’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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