510(k) Report

FDA applicant

Guardian Group, Inc.

San Diego, CA2 decisions1994–19940 recalls

FDA records 2 decisions for Guardian Group, Inc. (San Diego, CA) in 1994: 2 510(k) clearances. All are in product code LZC (Medical Glove, Specialty). 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 Guardian Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guardian Group, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Guardian Group, 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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Other applicant names beginning “Guardian”

FDA records each applicant name separately; these may or may not be the same firm.