510(k) Report

FDA applicant

Guardian Chemical

Smithtown, NY2 decisions1984–19840 recalls

FDA records 2 decisions for Guardian Chemical (Smithtown, NY) in 1984: 2 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and FKQ (System, Dialysate Delivery, Central Multiple…). 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 Chemical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guardian Chemical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Guardian”

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