Cleared Traditional

K131542 - NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC

K131542 · Novabay Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
56d
Days
-
Risk

K131542 is an FDA 510(k) clearance for the NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Novabay Pharmaceuticals, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 56 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 Novabay Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K131542

510(k) Number K131542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2013
Decision Date July 24, 2013
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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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