Cleared Traditional

K971612 - OSMO/PCA PILLOW WOUND DRESSING

K971612 is an FDA 510(k) clearance for OSMO/PCA 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 318-day FDA review.

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

FDA 510(k) Submission Details - K971612

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 115d · This submission: 318d
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 K971612.
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company · Oct 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
NONWOVEN PAD
K980720 · Convatec, A Division of E.R. Squibb & Sons · Apr 1998
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