510(k) Report

FDA applicant

National Healthcare Linen Service

Safety Harbor, FL4 decisions1993–19940 recalls

FDA records 4 decisions for National Healthcare Linen Service (Safety Harbor, FL) from 1993 to 1994: 4 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KKX (Drape, Surgical, Antimicrobial). 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 and plastic surgery panel, where it files most

How often FDA has decided National Healthcare Linen Service’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National Healthcare Linen Service since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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