Cleared Traditional

K031263 - 3M LIQUID BANDAGE, MODEL 120-LB

K031263 is an FDA 510(k) clearance for 3M LIQUID BANDAGE, manufactured by 3M Company. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K031263 · 3M Company · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
169d
Days
Class 1
Risk

K031263 is an FDA 510(k) clearance for the 3M LIQUID BANDAGE, MODEL 120-LB. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on October 7, 2003 after a review of 169 days - an extended review cycle.

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. 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 Company devices

FDA 510(k) Submission Details - K031263

510(k) Number K031263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date October 07, 2003
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
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 144
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K031263.
3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082 · Medtrade Products , Ltd. · Nov 2005
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004
FERRIS POLYOSTOMY STERILE WOUND DRESSING
K991729 · Ferris Mfg. Corp. · Aug 1999
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
K992032 · Acrymed, Inc. · Aug 1999
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
K991920 · Dermaphylyx, Inc. · Aug 1999