510(k) Report

510(k) · Cleared

Cleared

Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional Liquid Bandage

K050757510(k) TraditionalCleared Feb 23, 2006337-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

Chemence Medical, Inc. · KMF Bandage, Liquid

Cleared on Feb 23, 2006 as substantially equivalent to K031263 (3M Company, 2003) and 1 other predicate after a 337-day review. Its family tree reaches back 2 generations to 2001. 6 later devices descend from it.

Decided
Feb 23, 2006
Review
337 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K002338 (2001). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2007: 1 descendant cleared2009: 2 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant clearedK002338 · Liquiderm Liquid Adhesive Bandage · Closure Medical Corp. · 2001K031321 · Liquishield Liquid Bandage, Model LSB 0001 · Medlogic Global Limited · 2004200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K031321 · Liquishield Liquid Bandage, Model LSB 0001 · Medlogic Global Limited · 2004K002338 · Liquiderm Liquid Adhesive Bandage · Closure Medical Corp. · 20010
  1. Root · 2 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
  2. 1 generation backK031321 Liquishield Liquid Bandage, Model LSB 0001Medlogic Global Limited · 2004
  3. This deviceK050757 Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive…Chemence Medical, Inc. · 2006
  4. Descendant · cites it directly · 5 of its ownK063202 Proderma Liquid BandageProcurement Technology Systems, LLC · 2007
  5. Descendant · 2 generations on · 3 of its ownK083913 Chesson Labs Liquid BandageChesson Laboratory Associates, Inc. · 2009
  6. Descendant · 3 generations on · 2 of its ownK131384 Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage…Kericure, Inc. · 2014
  7. Descendant · 4 generations on · 0 of its ownK182733 Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019
  8. Descendant · 4 generations on · 0 of its ownK171148 Aleo BME Liquid BandageAleo Bme, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22014: 12018: 12019: 1
2007high 2 (2009) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K063202Proderma Liquid BandageProcurement Technology Systems, LLC · 2007 · cites it directly5descendants
  • K083913Chesson Labs Liquid BandageChesson Laboratory Associates, Inc. · 2009 · 2 generations on3descendants
  • K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKericure, Inc. · 2014 · 3 generations on2descendants
  • K182733Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019 · 4 generations on0descendants
  • K171148Aleo BME Liquid BandageAleo Bme, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002338Liquiderm Liquid Adhesive BandageClosure Medical Corp.2001—
−1K031321Liquishield Liquid Bandage, Model LSB 0001Medlogic Global Limited2004—
0 (this device)K050757Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional…Chemence Medical, Inc.2006—
+1K063202Proderma Liquid BandageProcurement Technology Systems, LLC2007—
+2K083913Chesson Labs Liquid BandageChesson Laboratory Associates, Inc.2009—
+3K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKericure, Inc.2014—
+4K182733Rochal Bioshield Silicone FilmRochal Industries, LLC2019—
+4K171148Aleo BME Liquid BandageAleo Bme, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200920
201410
201810
201910
FIG. 1 — Lineage of K050757, 2001–2019Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK003138Liquiderm Liquid Adhesive Bandage
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*K0312633M Liquid Bandage, Model 120-LB
Summary page 1
…Bandage). 3M T'm Liquid Bandage, which is manufactured by 3M Health Care, K031263, (Marketed as 3M NEXCARE T Liquid Bandage). LiquiShieldm Liqu…
3M Company2003—
*K031321Liquishield Liquid Bandage, Model LSB 0001
Summary page 1
…Liquid Bandage). LiquiShieldm Liquid Bandage, which is manufactured by MedLogic Global Limited, K03132 1. Contraindications: Care should be used around the eyes. Do not use on skin wit…
Medlogic Global Limited2004—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K063202Proderma Liquid BandageProcurement Technology Systems, LLC20075

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?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K063202 (Procurement Technology Systems, LLC, 2007) has gone furthest, with 5 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?

DERMA+FLEX Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K050757: Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional Liquid Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050757

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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