Cleared Traditional

K962623 - OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING

K962623 is an FDA 510(k) clearance for OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING, manufactured by Procyte Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K962623 · Procyte Corp. · General & Plastic Surgery device
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Nov 1996
Decision
144d
Days
Class 1
Risk

K962623 is an FDA 510(k) clearance for the OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Procyte Corp. (Kirkland, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Procyte Corp. devices

FDA 510(k) Submission Details - K962623

510(k) Number K962623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date November 26, 1996
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 108
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K962623.
ULTRAFERA WOUND DRESSING
K964614 · American White Cross, Inc. · Feb 1997
TIELLE HYDROPOLYMER FOAM DRESSING
K964016 · Johnson & Johnson Medical, Inc. · Dec 1996
DERMAGRAN HYDROPHILIC OINTMENT
K963603 · Derma Sciences, Inc. · Nov 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc. · Oct 1996
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K961323 · Acme United Corp. · Jun 1996
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
K961452 · Acme United Corp. · May 1996