510(k) · Cleared
ClearedMepitel AG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke Health Care · FRO Dressing, Wound, Drug
Cleared on Feb 12, 2014 as substantially equivalent to K984371 (Molnlycke Health Care, Inc., 1999) and 1 other predicate after a 401-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Feb 12, 2014
- Review
- 401 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970566 (1997). 17 ancestors in all, the oldest K871166 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 5 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- 4 generations backK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
- 3 generations backK061220 Urgotul AGLaboratoires Urgo · 2006
- 2 generations backK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- 1 generation backK100430 Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010
- This deviceK130040 Mepitel AGMolnlycke Health Care · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −5 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| −4 | K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X… | Coloplast Corp. | 2002 | — |
| −3 | K061220 | Urgotul AG | Laboratoires Urgo | 2006 | — |
| −2 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| −1 | K100430 | Urgotul AG, Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2010 | — |
| 0 (this device) | K130040 | Mepitel AG | Molnlycke Health Care | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
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 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984371 | Mepitel Non Adherent Silicone DressingSummary page 2…o clinical data was required. Conclusion: Based on the information presented in this submission, it can be concluded that the Mepitel® Ag is equivalent to the Mepitel® (K984371) and the Urgotul® Ag (K100430) predicate devices with respect to intended use, materials, design, and technological characteristi… | 1999 |
| * | K100430 | Urgotul AG, Antimicrobial Wound Dressing with SilverSummary page 2…Conclusion: Based on the information presented in this submission, it can be concluded that the Mepitel® Ag is equivalent to the Mepitel® (K984371) and the Urgotul® Ag (K100430) predicate devices with respect to intended use, materials, design, and technological characteristics. *DEPARTMEN… | 2010 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 17 ancestors has a recall.
- 3 other devices also cite its predicate K984371.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
MelpiteP Ag is intended for the management of a wide range of exuding wounds such as skin tears, skin abrasions, sutured/surgical wounds, partial thickness burns, partial and ful thickness grafts, lacerations, diabetic ulcers, venous ulcers, end arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130040: Mepitel AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130040
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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