Cleared Traditional

K972150 - OSMOCYTE ISLAND WOUND DRESSING

K972150 is an FDA 510(k) clearance for OSMOCYTE ISLAND 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 184-day FDA review.

K972150 · Procyte Corp. · General & Plastic Surgery device
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Dec 1997
Decision
184d
Days
Class 1
Risk

K972150 is an FDA 510(k) clearance for the OSMOCYTE ISLAND WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Procyte Corp. (Redmond, US). The FDA issued a Cleared decision on December 10, 1997 after a review of 184 days - an extended review 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: 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 - K972150

510(k) Number K972150 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 09, 1997
Decision Date December 10, 1997
Days to Decision 184 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 115d · This submission: 184d
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 107
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K972150.
NON-WOVEN COMPRESS
K980382 · Convatec, A Division of E.R. Squibb & Sons · Mar 1998
NONWOVEN DRESSING
K974823 · Convatec, A Division of E.R. Squibb & Sons · Feb 1998
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
K974205 · Convatec, A Division of E.R. Squibb & Sons · Feb 1998
OSMOCYTE RA WOUND DRESSING
K972329 · Procyte Corp. · Dec 1997
KENDALL CURITY NON-ADHERING DRESSING
K973619 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997