510(k) · Cleared
ClearedEuromed Sureskin Iii with Silver Wound Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euromed, Inc. · FRO Dressing, Wound, Drug
Cleared on May 17, 2006 as substantially equivalent to K013525 (Coloplast Corp., 2002) and 2 other predicates after a 495-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.
- Decided
- May 17, 2006
- Review
- 495 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K853844 (1985). 18 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK853844 Duoderm Hydroactive Dressing W/Border SterileConvatec, A Division of E.R. Squibb & Sons · 1985
- 2 generations backK983249 Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998
- 1 generation backK992363 Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc. · 1999
- This deviceK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK081274 Sureskin Silver BandagesEuromed, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK151186 Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −3 | K853844 | Duoderm Hydroactive Dressing W/Border Sterile | Convatec, A Division of E.R. Squibb & Sons | 1985 | — |
| −2 | K983249 | Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin | Euromed, Inc. | 1998 | — |
| −1 | K992363 | Sureskin II Standard, Sureskin II Border, Sureskin II Thin | Euromed, Inc. | 1999 | — |
| 0 (this device) | K050032 | Euromed Sureskin Iii with Silver Wound Dressings | Euromed, Inc. | 2006 | — |
| +1 | K081274 | Sureskin Silver Bandages | Euromed, Inc. | 2008 | — |
| +1 | K151186 | Stay Fresh Hydrocolloid dressing | Sarasota Medical Products, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Summary page 1…Classification Name: Occlusive Wound and Burn Dressing 3. PREDICATE DEVICES * Contreet Antimicrobial Wound Dressing K013525 * Xylos Corporation Cell Antimicrobial Wound Dressing K024054 * SureSkin II Wound Dressings… | 2002 |
| * | K024054 | Xylos Xcell Antimicrobial DressingSummary page 1…ES * Contreet Antimicrobial Wound Dressing K013525 * Xylos Corporation Cell Antimicrobial Wound Dressing K024054 * SureSkin II Wound Dressings K992363 4. DEVICE DESCRIPTION The Sur… | 2003 |
| * | K992363 | Sureskin II Standard, Sureskin II Border, Sureskin II ThinSummary page 1…525 * Xylos Corporation Cell Antimicrobial Wound Dressing K024054 * SureSkin II Wound Dressings K992363 4. DEVICE DESCRIPTION The SureSkin I with Silver Wound Dressings are identical to the SureSkin II products wi… | 1999 |
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 21 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K081274 (Euromed, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K013525.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SureSkin In with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
The SureSkin II with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkinTM III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.
The SureSkinTM III with Silver wound dressings are also indicated for use on second degree bums and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050032: Euromed Sureskin Iii with Silver Wound Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050032
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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