Cleared Traditional

K925618 - 3M REMOVER LOTION PRODUCT NUMBER 86XX

K925618 is the FDA 510(k) clearance for 3M REMOVER LOTION PRODUCT NUMBER 86XX by 3M Health Care, Ltd.. It is a Class 1 General & Plastic Surgery device (product code KOX) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K925618 · 3M Health Care, Ltd. · General & Plastic Surgery device
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Mar 1993
Decision
145d
Days
Class 1
Risk

K925618 is an FDA 510(k) clearance for the 3M REMOVER LOTION PRODUCT NUMBER 86XX. Classified as Solvent, Adhesive Tape (product code KOX), Class I - General Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 145 days - within the typical 510(k) review window.

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: 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 3M Health Care, Ltd. devices

Submission Details

510(k) Number K925618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date March 31, 1993
Days to Decision 145 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
30d slower than avg
Panel avg: 115d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K925618.
ALLKARE(TM) ADHESIVE REMOVER WIPE
K924976 · Convatec, A Division of E.R. Squibb & Sons · Apr 1993
SKIN SUPPORT PREP PAD
K923351 · Coloplast Corp. · Sep 1992
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