Cleared Traditional

NEUTROPHASE (K081009) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K081009 · Novabay Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
42d
Days
Class 1
Risk

K081009 is an FDA 510(k) clearance for the NEUTROPHASE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Novabay Pharmaceuticals (Emeryville, US). The FDA issued a Cleared decision on May 20, 2008 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. 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 devices

Submission Details

510(k) Number K081009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2008
Decision Date May 20, 2008
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K081009.
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Aleo BME Liquid Bandage
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VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
DRESSING, ENVIRON WOUND
K782008 · Abbott Laboratories · May 1979
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406 · Abbott Laboratories · Sep 1978