Cleared Traditional

K121522 - POLYFIT ABSORBING ANTIMICROBIAL DRESSIN...

K121522 · Polyremedy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
35d
Days
-
Risk

K121522 is an FDA 510(k) clearance for the POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Polyremedy, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 35 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 Polyremedy, Inc. devices

FDA 510(k) Submission Details - K121522

510(k) Number K121522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2012
Decision Date June 27, 2012
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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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