510(k) Report

FDA applicant

Western Systems, Inc.

Mchenry, IL1 decision1982–19820 recalls

FDA records 1 decision for Western Systems, Inc. (Mchenry, IL) in 1982: 1 510(k) clearance. All are in product code FRF (Cleaner, Air, Medical Recirculating). 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 Western Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Western Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Western”

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