510(k) Report

510(k) · Cleared

Cleared

Curad Scar Therapy

K024057510(k) TraditionalCleared Jun 18, 2003191-day reviewClass I21 CFR 878.4025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beiersdorf, Inc. · MDA Elastomer, Silicone, For Scar Management

Cleared on Jun 18, 2003 as substantially equivalent to K944581 (Beiersdorf, Inc., 1994) and 1 other predicate after a 191-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jun 18, 2003
Review
191 days
Class
Class I
Product code
MDA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944581 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK944581 · Cutinova Thin Wound Dressing · Beiersdorf, Inc. · 19941990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K944581 · Cutinova Thin Wound Dressing · Beiersdorf, Inc. · 19940
  1. Root · 1 generation backK944581 Cutinova Thin Wound DressingBeiersdorf, Inc. · 1994
  2. This deviceK024057 Curad Scar TherapyBeiersdorf, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944581Cutinova Thin Wound DressingBeiersdorf, Inc.1994—
0 (this device)K024057Curad Scar TherapyBeiersdorf, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K024057, 1994–2003Source: 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

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
*K944581Cutinova Thin Wound DressingBeiersdorf, Inc.1994—
*K974354Mepiform Adherent Silicone Dressing for Scar CareSca Molnlycke1998—

Also cleared against K944581: 1 other device →

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K944581.

How does its category compare?

All MDA devices

MDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDA

2in 2011

2009: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDA

Too few MDA 510(k)s in any year since 2007 to give a median.

Recalls per year · MDA

No recall names MDA since 2007.

Adverse event reports per year · MDA

3in 2025

2007: 32013: 22014: 12015: 22016: 52017: 32018: 22019: 52020: 42021: 32023: 82025: 3
2007high 8 (2023) · low 0 (2008)2025

MAUDE reports naming product code MDA, 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
20070—03
20080—00
20091—00
20100—00
20112—00
20120—00
20130—02
20140—01
20150—02
20160—05
20170—03
20180—02
20190—05
20200—04
20210—03
20220—00
20230—08
20240—00
20250—03
20260—0—

What is it indicated for?

Intended for the management of hypertrophic and keloid scars.

May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.

Indications for use as stated in the FDA summary.

Also cleared against K944581

1 other device cites the same predicate.

  • K984593Modification of Cutinova Thin DressingBeiersdorf-Jobt, Inc. · 1999

More from Beiersdorf, Inc.

45 FDA decisions under this applicant name. See the company

  • K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 &…Beiersdorf, Inc. · 2009
  • K952526Cutinova CavityBeiersdorf, Inc. · 1995
  • K943363Cutiplast SterilBeiersdorf, Inc. · 1995
  • K944581Cutinova Thin Wound DressingBeiersdorf, Inc. · 1994
  • K935630NORTABeiersdorf, Inc. · 1994

Recent decisions in MDA

The MDA category page

  • K112131Neodyne DressingNeodyne Biosciences, Inc. · 2011
  • K111733Coreleader Scar-DimmerCoreleader Biotech Co., Ltd. · 2011
  • K083718Beau RX Scar Care GelBeau RX Solutions, LLC · 2009
  • K053481Kelo-Cote SprayAdvanced Bio-Technologies, Inc. · 2006
  • K041704Newgel and Newgel Plus ENewmedical Technology, Inc. · 2005

https://510kreport.com/device/K024057 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024057: Curad Scar Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024057

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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