Cleared Traditional

K121407 - OXYBAND WOUND DRESSING

K121407 · O2s, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
60d
Days
-
Risk

K121407 is an FDA 510(k) clearance for the OXYBAND WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by O2s, LLC (Philadelphia, US). The FDA issued a Cleared decision on July 9, 2012 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all O2s, LLC devices

FDA 510(k) Submission Details - K121407

510(k) Number K121407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2012
Decision Date July 09, 2012
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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