FDA applicant
On Site Gas Systems, Inc.
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
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
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like On Site Gas Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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