FDA applicant
O2s, LLC
FDA records 1 decision for O2s, LLC (Philadelphia, PA) in 2012: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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 O2s, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2012high 1 (2012) · low 0 (2013)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like O2s, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report