510(k) Report

510(k) · Decided

Decided

Elastic Skin Liquid Bandage

K032948510(k) TraditionalDecided Jun 25, 2004277-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

Medpak, LLC · KMF Bandage, Liquid

Cleared on Jun 25, 2004 as substantially equivalent to K022645 (Beiersdorf AG, 2002) after a 277-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it.

Decided
Jun 25, 2004
Review
277 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K002338 (2001). 8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2012: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2022: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant clearedK002338 · Liquiderm Liquid Adhesive Bandage · Closure Medical Corp. · 2001K022645 · CURAD · Beiersdorf AG · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K022645 · CURAD · Beiersdorf AG · 2002K002338 · Liquiderm Liquid Adhesive Bandage · Closure Medical Corp. · 20010+5
  1. Root · 2 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
  2. 1 generation backK022645 CURADBeiersdorf AG · 2002
  3. This deviceK032948 Elastic Skin Liquid BandageMedpak, LLC · 2004
  4. Descendant · cites it directly · 7 of its ownK042610 DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005
  5. Descendant · 2 generations on · 6 of its ownK053625 NasalguardTrutek Corp · 2006
  6. Descendant · 3 generations on · 3 of its ownK132520 Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013
  7. Descendant · 4 generations on · 1 of its ownK170848 Alzair Allergy BlockerNasaleze International, Ltd. · 2017
  8. Descendant · 2 generations on · 1 of its ownK120894 HaymaxHaymax Limited · 2012

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12012: 12013: 12014: 12017: 12021: 12022: 1
2005high 1 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K042610DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005 · cites it directly7descendants
  • K053625NasalguardTrutek Corp · 2006 · 2 generations on6descendants
  • K132520Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013 · 3 generations on3descendants
  • K170848Alzair Allergy BlockerNasaleze International, Ltd. · 2017 · 4 generations on1descendant
  • K120894HaymaxHaymax Limited · 2012 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002338Liquiderm Liquid Adhesive BandageClosure Medical Corp.2001—
−1K022645CURADBeiersdorf AG2002—
0 (this device)K032948Elastic Skin Liquid BandageMedpak, LLC2004—
+1K042610DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH2005—
+2K053625NasalguardTrutek Corp2006—
+3K132520Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc.2013—
+4K170848Alzair Allergy BlockerNasaleze International, Ltd.2017—
+2K120894HaymaxHaymax Limited2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201210
201310
201410
201710
202110
202210
FIG. 1 — Lineage of K032948, 2001–2022Source: 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? (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
*K022645CURAD
Summary page 1
…1 CFR Ref. Panel Liquid Bandage KMF 880.5090 General &: Plastic Surgery 3.Predicate Device CURAD ® Spray Bandage, S10(k) No. K022645 4. Device Description Elastic Skin is a liquid solution film-forming product, The product solution is packaged in a container w…
Beiersdorf AG2002—

Also cleared against K022645: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K042610DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH20057

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 3 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K042610 (Dr. Theiss Naturwaren GmbH, 2005) has gone furthest, with 7 descendants of its own.
  • 3 other devices also cite its predicate K022645.

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?

Elastic Skin Liquid Bandage is indicated for providing a covering over minor wounds and scrapes that are clean and dry.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K032948: Elastic Skin Liquid Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032948

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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