510(k) Report

FDA applicant

On Site Gas Systems, Inc.

Newington, CT9 decisions2002–20100 recalls

FDA records 9 decisions for On Site Gas Systems, Inc. (Newington, CT) from 2002 to 2010: 9 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 14 predicates, 7 of them its own earlier devices. 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, anesthesiology panel, where it files most

How often FDA has decided On Site Gas Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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