Cleared Traditional

K915150 - REMOVE ADHESIVE REMOVER

K915150 is an FDA 510(k) clearance for REMOVE ADHESIVE REMOVER, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KOX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K915150 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Jan 1992
Decision
56d
Days
Class 1
Risk

K915150 is an FDA 510(k) clearance for the REMOVE ADHESIVE REMOVER. Classified as Solvent, Adhesive Tape (product code KOX), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 56 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 Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K915150

510(k) Number K915150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1991
Decision Date January 09, 1992
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K915150.
ALLKARE(TM) ADHESIVE REMOVER WIPE
K924976 · Convatec, A Division of E.R. Squibb & Sons · Apr 1993
3M REMOVER LOTION PRODUCT NUMBER 86XX
K925618 · 3M Health Care, Ltd. · Mar 1993
SKIN SUPPORT PREP PAD
K923351 · Coloplast Corp. · Sep 1992
REMOVE ADHESIVE REMOVER
K893603 · Smith & Nephew United, Inc. · Jul 1989
ADHESIVE REMOVER
K821162 · The Healthcare Group Laboratories, Inc. · May 1982