510(k) · Cleared
ClearedUrgotul AG, Antimicrobial Wound Dressing with Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratoires Urgo · FRO Dressing, Wound, Drug
Cleared on Jun 11, 2010 as substantially equivalent to K061220 (Laboratoires Urgo, 2006) and 1 other predicate after a 115-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 11, 2010
- Review
- 115 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970566 (1997). 14 ancestors in all, the oldest K871166 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 4 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- 3 generations backK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
- 2 generations backK061220 Urgotul AGLaboratoires Urgo · 2006
- 1 generation backK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- This deviceK100430 Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010
- Descendant · cites it directly · 0 of its ownK242758 Atrauman® AgHartmann USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK130040 Mepitel AGMolnlycke Health Care · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −4 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| −3 | K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X… | Coloplast Corp. | 2002 | — |
| −2 | K061220 | Urgotul AG | Laboratoires Urgo | 2006 | — |
| −1 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| 0 (this device) | K100430 | Urgotul AG, Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2010 | — |
| +1 | K242758 | Atrauman® Ag | Hartmann USA, Inc. | 2024 | — |
| +1 | K130040 | Mepitel AG | Molnlycke Health Care | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K061220 | Urgotul AGSummary page 1…on or Usual Name: Antimicrobial Wound Dressing with Silver Proprietary Name: Urgotul Ag Classification Name: Unclassified 3. Predicate Devices: Urgotul Ag (K061220), Laboratoires URGO Urgocell Ag (K062559), Laboratoires URGO 4. Description of Device Urgotul®D Ag, antimicrobial wound dr… | 2006 |
| * | K062559 | Urgocell AG Antimicrobial Wound Dressing with SilverSummary page 1…ng with Silver Proprietary Name: Urgotul Ag Classification Name: Unclassified 3. Predicate Devices: Urgotul Ag (K061220), Laboratoires URGO Urgocell Ag (K062559), Laboratoires URGO 4. Description of Device Urgotul®D Ag, antimicrobial wound dressing with silver, is a non-adhesive, no… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K242758 (Hartmann USA, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061220.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100430: Urgotul AG, Antimicrobial Wound Dressing with Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100430
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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