510(k) · Cleared
ClearedSureskin Silver Bandages
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 28, 2008 as substantially equivalent to K050032 (Euromed, Inc., 2006) after a 23-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- May 28, 2008
- Review
- 23 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853844 (1985). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK853844 Duoderm Hydroactive Dressing W/Border SterileConvatec, A Division of E.R. Squibb & Sons · 1985
- 3 generations backK983249 Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998
- 2 generations backK992363 Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc. · 1999
- 1 generation backK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
- This deviceK081274 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 1 of 1 · See all- K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853844 | Duoderm Hydroactive Dressing W/Border Sterile | Convatec, A Division of E.R. Squibb & Sons | 1985 | — |
| −3 | K983249 | Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin | Euromed, Inc. | 1998 | — |
| −2 | K992363 | Sureskin II Standard, Sureskin II Border, Sureskin II Thin | Euromed, Inc. | 1999 | — |
| −1 | K050032 | Euromed Sureskin Iii with Silver Wound Dressings | Euromed, Inc. | 2006 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K050032 | Euromed Sureskin Iii with Silver Wound DressingsSummary page 1…SureSkin Silver is substantially equivalent in function, construction, and chemical composition to Euromed SureSkin III with Silver Wound Dressings (Rx) cleared by FDA (K050032). The primary purpose of this 5 10(k) is to seek clearance for Over-The- Counter (OTC) marketing of this dressing with revised in… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151186 | Stay Fresh Hydrocolloid dressing | 2015 | 0 |
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 23 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K151186 (Sarasota Medical Products, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050032.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters and scalds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081274: Sureskin Silver Bandages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081274
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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