510(k) Report

510(k) · Cleared

Cleared

3M Liquid Bandage, Model 120-LB

K031263510(k) TraditionalCleared Oct 7, 2003169-day reviewClass I21 CFR 880.5090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

3M Company · KMF Bandage, Liquid

Cleared on Oct 7, 2003 after a 169-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Oct 7, 2003
Review
169 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK031263 3M Liquid Bandage, Model 120-LB3M Company · 2003
  2. Descendant · cites it directly · 6 of its ownK050757 Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive…Chemence Medical, Inc. · 2006
  3. Descendant · 2 generations on · 5 of its ownK063202 Proderma Liquid BandageProcurement Technology Systems, LLC · 2007
  4. Descendant · 3 generations on · 3 of its ownK083913 Chesson Labs Liquid BandageChesson Laboratory Associates, Inc. · 2009
  5. Descendant · 4 generations on · 2 of its ownK131384 Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage…Kericure, Inc. · 2014
  6. Descendant · 5 generations on · 0 of its ownK182733 Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12009: 22014: 12018: 12019: 1
2006high 2 (2009) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K050757Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional Liquid BandageChemence Medical, Inc. · 2006 · cites it directly6descendants
  • K063202Proderma Liquid BandageProcurement Technology Systems, LLC · 2007 · 2 generations on5descendants
  • K083913Chesson Labs Liquid BandageChesson Laboratory Associates, Inc. · 2009 · 3 generations on3descendants
  • K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKericure, Inc. · 2014 · 4 generations on2descendants
  • K182733Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0312633M Liquid Bandage, Model 120-LB3M Company2003—
+1K050757Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional…Chemence Medical, Inc.2006—
+2K063202Proderma Liquid BandageProcurement Technology Systems, LLC2007—
+3K083913Chesson Labs Liquid BandageChesson Laboratory Associates, Inc.2009—
+4K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKericure, Inc.2014—
+5K182733Rochal Bioshield Silicone FilmRochal Industries, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200920
201410
201810
201910
FIG. 1 — Lineage of K031263, 2003–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KMF device

  1. #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Johnson & Johnson BAND-AID® Liquid Bandage
Named without a submission number
—

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050757Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional Liquid BandageChemence Medical, Inc.20066

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050757 (Chemence Medical, Inc., 2006) has gone furthest, with 6 descendants of its own.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMF

1in 2024

2007: 22008: 32009: 32010: 12012: 12014: 22016: 22018: 12019: 12024: 1
2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2008: 35 days median2009: 213 days median
2007high 213 (2009) · low 35 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KMF

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KMF

12in 2025

2007: 62008: 22009: 62010: 72011: 162012: 32013: 342014: 242015: 132016: 182017: 162018: 102019: 62020: 82021: 102022: 72023: 62024: 62025: 12
2007high 34 (2013) · low 2 (2008)2025

MAUDE reports naming product code KMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—16
200833502
2009321306
20101—07
20110—116
20121—03
20130—034
20142—024
20150—013
20162—018
20170—016
20181—010
20191—06
20200—08
20210—010
20220—07
20230—06
20241—06
20250—012
20260—0—

What is it indicated for?

3MTMLiquid Bandage is intended to cover minor cuts, scrapes, and skin irritations.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K031263: 3M Liquid Bandage, Model 120-LB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031263

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026