510(k) Report

510(k) · Cleared

Cleared

Mepilex AG Absorbent Silicone-Coated Dressing

K061554510(k) TraditionalCleared Jan 25, 2007234-day reviewClass U

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

Molnlycke Health Care · FRO Dressing, Wound, Drug

Cleared on Jan 25, 2007 after a 234-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Jan 25, 2007
Review
234 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

14 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2010: 1 descendant cleared2007: 1 descendant cleared2024: 2 descendants cleared2023: 2 descendants cleared2016: 1 descendant cleared2013: 3 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK061554 Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care · 2007
  2. Descendant · cites it directly · 9 of its ownK100029 Mepilex Border AG DressingMolnlycke Health Care · 2010
  3. Descendant · 2 generations on · 3 of its ownK160022 LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016
  4. Descendant · cites it directly · 3 of its ownK083133 Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing…Andover Healthcare, Inc. · 2009
  5. Descendant · 2 generations on · 2 of its ownK170077 LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017
  6. Descendant · 2 generations on · 2 of its ownK123892 Mepilex Transfer AGMolnlycke Health Care · 2013

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22010: 12013: 32016: 12017: 12020: 12023: 22024: 2
2007high 3 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 14 · See all
  • K100029Mepilex Border AG DressingMolnlycke Health Care · 2010 · cites it directly9descendants
  • K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016 · 2 generations on3descendants
  • K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc. · 2009 · cites it directly3descendants
  • K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017 · 2 generations on2descendants
  • K123892Mepilex Transfer AGMolnlycke Health Care · 2013 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061554Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care2007—
+1K100029Mepilex Border AG DressingMolnlycke Health Care2010—
+2K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.2016—
+1K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex…Andover Healthcare, Inc.2009—
+2K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.2017—
+2K123892Mepilex Transfer AGMolnlycke Health Care2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200920
201010
201330
201610
201710
202010
202320
202420
FIG. 1 — Lineage of K061554, 2007–2024Source: 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 FRO? 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 FRO device

  1. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*—Contreet Foam Dressings
Named without a submission number
—
*—3M Tegaderm Silver Nonwoven Dressing
Named without a submission number
—
*—Mepilex Absorbent Silicone-Coated Dressing
Named without a submission number
—

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K100029Mepilex Border AG DressingMolnlycke Health Care20109
K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093
K071354Mepilex AG DressingMonlycke Health Care20071
K091013Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited20090

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, K100029 (Molnlycke Health Care, 2010) has gone furthest, with 9 descendants of its own.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, 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
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Mepelix Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.

Indications for use as stated in the FDA summary.

More from Molnlycke Health Care

9 FDA decisions under this applicant name. See the company

  • K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014
  • K130040Mepitel AGMolnlycke Health Care · 2014
  • K123892Mepilex Transfer AGMolnlycke Health Care · 2013
  • K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film…Molnlycke Health Care · 2013
  • K102923Barrier N95 Particulate RespiratorMolnlycke Health Care · 2010

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K061554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061554: Mepilex AG Absorbent Silicone-Coated Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061554

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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