Cleared Traditional

K923351 - SKIN SUPPORT PREP PAD

K923351 is an FDA 510(k) clearance for SKIN SUPPORT PREP PAD, manufactured by Coloplast Corp.. The device is a Class 1 General & Plastic Surgery device with product code KOX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K923351 · Coloplast Corp. · General & Plastic Surgery device
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Sep 1992
Decision
68d
Days
Class 1
Risk

K923351 is an FDA 510(k) clearance for the SKIN SUPPORT PREP PAD. Classified as Solvent, Adhesive Tape (product code KOX), Class I - General Controls.

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4730 - 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 Coloplast Corp. devices

FDA 510(k) Submission Details - K923351

510(k) Number K923351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date September 14, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

KOX Device Classification - Class 1, General Controls

Product Code KOX Solvent, Adhesive Tape
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4730
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 - KOX Solvent, Adhesive Tape

Devices cleared under the same product code (KOX) and FDA review panel - the closest regulatory comparables to K923351.
ALLKARE(TM) ADHESIVE REMOVER WIPE
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REMOVE ADHESIVE REMOVER
K915150 · Smith & Nephew United, Inc. · Jan 1992
REMOVE ADHESIVE REMOVER
K893603 · Smith & Nephew United, Inc. · Jul 1989
ADHESIVE REMOVER
K821162 · The Healthcare Group Laboratories, Inc. · May 1982