Cleared Traditional

OSMO/PCA PILLOW WOUND DRESSING (K971612) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K971612 · Procyte Corp. · General & Plastic Surgery device
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Mar 1998
Decision
318d
Days
Class 1
Risk

K971612 is an FDA 510(k) clearance for the OSMO/PCA 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 March 16, 1998 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K971612 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 02, 1997
Decision Date March 16, 1998
Days to Decision 318 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 115d · This submission: 318d
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 15
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K971612.
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company · Oct 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982