510(k) Report

510(k) · Cleared

Cleared

3M NO Sting Barrier Film

K955103510(k) TraditionalCleared Feb 5, 199689-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 Medical Products Group · KMF Bandage, Liquid

Cleared on Feb 5, 1996 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Feb 5, 1996
Review
89 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2003: 1 descendant cleared1998: 1 descendant cleared2016: 2 descendants cleared2009: 1 descendant cleared2006: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955103 3M NO Sting Barrier Film3M Medical Products Group · 1996
  2. Descendant · cites it directly · 2 of its ownK023163 Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS…Medlogic Global Limited · 2003
  3. Descendant · 2 generations on · 1 of its ownK083087 EcocelPolichem S.A · 2009
  4. Descendant · cites it directly · 1 of its ownK980117 Nuvo Barrier FilmBiomedical Development Co. · 1998
  5. Descendant · cites it directly · 0 of its ownK153571 Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016
  6. Descendant · cites it directly · 0 of its ownK160684 Atteris No-Sting Skin ProtectantRochal Industries, LLC · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12005: 12006: 12009: 12012: 12016: 2
1998high 2 (2016) · low 0 (1999)2026

Most influential descendants

Showing 5 of 8 · See all
  • K023163Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020Medlogic Global Limited · 2003 · cites it directly2descendants
  • K083087EcocelPolichem S.A · 2009 · 2 generations on1descendant
  • K980117Nuvo Barrier FilmBiomedical Development Co. · 1998 · cites it directly1descendant
  • K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016 · cites it directly0descendants
  • K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9551033M NO Sting Barrier Film3M Medical Products Group1996—
+1K023163Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020Medlogic Global Limited2003—
+2K083087EcocelPolichem S.A2009—
+1K980117Nuvo Barrier FilmBiomedical Development Co.1998—
+1K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare2016—
+1K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200510
200610
200910
201210
201620
FIG. 1 — Lineage of K955103, 1996–2016Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023163Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020Medlogic Global Limited20032
K980117Nuvo Barrier FilmBiomedical Development Co.19981
K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare20160
K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC20160
K051082Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved)Medtrade Products, Ltd.20050

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, K023163 (Medlogic Global Limited, 2003) has gone furthest, with 2 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—
Cite this page

510(k) Report. “K955103: 3M NO Sting Barrier Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955103

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026