510(k) Report

510(k) · Cleared

Cleared

Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020

K023163510(k) TraditionalCleared Jan 13, 2003112-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

Medlogic Global Limited · KMF Bandage, Liquid

Cleared on Jan 13, 2003 as substantially equivalent to K955103 (3M Medical Products Group, 1996) after a 112-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.

Decided
Jan 13, 2003
Review
112 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K955103 (1996). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 1 descendant clearedK955103 · 3M NO Sting Barrier Film · 3M Medical Products Group · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K955103 · 3M NO Sting Barrier Film · 3M Medical Products Group · 19960
  1. Root · 1 generation backK955103 3M NO Sting Barrier Film3M Medical Products Group · 1996
  2. This deviceK023163 Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS…Medlogic Global Limited · 2003
  3. Descendant · cites it directly · 1 of its ownK083087 EcocelPolichem S.A · 2009
  4. Descendant · 2 generations on · 0 of its ownK120059 Liquid BandageChesson Laboratory Associates, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K083087EcocelPolichem S.A · 2009 · cites it directly1descendant
  • K120059Liquid BandageChesson Laboratory Associates, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
FIG. 1 — Lineage of K023163, 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
*K9551033M NO Sting Barrier Film
Summary page 1
…: 3M No Sting Barrier Film 3M Medical Products Group K955103 Intended Use: LiquiShieldTM-Sis intended to protect intact or damaged skin from the effects of moisture, fri…
3M Medical Products Group1996—

Also cleared against K955103: 4 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K083087EcocelPolichem S.A20091

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?

  • Its one ancestor has no recall.
  • Of its descendants, K083087 (Polichem S.A, 2009) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K955103.

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?

LiquiShield-S is intended to protect intact or damaged skin from the effects of moisture, friction (rubbing), or shear (tearing).

LiquiShield-S helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage.

LiquiShield-S can also be used in areas that are exposed to friction and shear such as occurs when items, such as bedding, clothing, or shoes, rub against the skin.

LiquiShield-S helps protect the skin against irritation caused by adhesive products

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K023163: Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023163

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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