FDA applicant

Isolation Systems, Inc.

Tonawanda, NY1 decision2002–20020 recalls

FDA records 1 decision for Isolation Systems, Inc. (Tonawanda, NY) in 2002: 1 510(k) clearance. All are in product code LGM (Chamber, Patient Isolation). 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 Isolation Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Isolation Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?