510(k) Report

510(k) · Cleared

Cleared

Liquid Bandage

K120059510(k) TraditionalCleared May 17, 2012129-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

Chesson Laboratory Associates, Inc. · KMF Bandage, Liquid

Cleared on May 17, 2012 as substantially equivalent to K083087 (Polichem S.A, 2009) after a 129-day review. Its family tree reaches back 3 generations to 1996.

Decided
May 17, 2012
Review
129 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K955103 (1996). 4 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 3 generations backK955103 3M NO Sting Barrier Film3M Medical Products Group · 1996
  2. 2 generations backK023163 Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS…Medlogic Global Limited · 2003
  3. 1 generation backK083087 EcocelPolichem S.A · 2009
  4. This deviceK120059 Liquid BandageChesson Laboratory Associates, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K9551033M NO Sting Barrier Film3M Medical Products Group1996—
−2K023163Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020Medlogic Global Limited2003—
−1K083087EcocelPolichem S.A2009—
0 (this device)K120059Liquid BandageChesson Laboratory Associates, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K120059, 1996–2012Source: 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
*K083087Ecocel
Summary page 2
…to be determined Common or usual name: Liquid bandage Classification name: CIFR 880.5090 Class I Legally marketed device to which equivalence is claimed: Ecocel® [K083087] Product description: This product for nail dystrophy isa biocompatible, polymeric lacquer that is applied directly to th…
Polichem S.A2009—

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
  • None of the 4 ancestors has a recall.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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?

[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120059: Liquid Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120059

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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