510(k) · Cleared
ClearedStay Fresh Hydrocolloid dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sarasota Medical Products, Inc. · FRO Dressing, Wound, Drug
Cleared on Nov 27, 2015 as substantially equivalent to K050032 (Euromed, Inc., 2006) and 1 other predicate after a 207-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Nov 27, 2015
- Review
- 207 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K853844 (1985). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK853844 Duoderm Hydroactive Dressing W/Border SterileConvatec, A Division of E.R. Squibb & Sons · 1985
- 4 generations backK983249 Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998
- 3 generations backK992363 Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc. · 1999
- 2 generations backK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
- 1 generation backK081274 Sureskin Silver BandagesEuromed, Inc. · 2008
- This deviceK151186 Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853844 | Duoderm Hydroactive Dressing W/Border Sterile | Convatec, A Division of E.R. Squibb & Sons | 1985 | — |
| −4 | K983249 | Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin | Euromed, Inc. | 1998 | — |
| −3 | K992363 | Sureskin II Standard, Sureskin II Border, Sureskin II Thin | Euromed, Inc. | 1999 | — |
| −2 | K050032 | Euromed Sureskin Iii with Silver Wound Dressings | Euromed, Inc. | 2006 | — |
| −1 | K081274 | Sureskin Silver Bandages | Euromed, Inc. | 2008 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K050032 | Euromed Sureskin Iii with Silver Wound DressingsSummary page 4…FRO Classification Name: Dressing, Wound, Drug Device Class: Unclassified 3. PREDICATE/REFERENCE DEVICES Primary Predicate Device K050032 & K081274 Euromed SureSkin Silver Wound Dressings and SureSkin Silver Bandage Reference Devices… | 2006 |
| * | K081274 | Sureskin Silver BandagesSummary page 4…assification Name: Dressing, Wound, Drug Device Class: Unclassified 3. PREDICATE/REFERENCE DEVICES Primary Predicate Device K050032 & K081274 Euromed SureSkin Silver Wound Dressings and SureSkin Silver Bandage Reference Devices… | 2008 |
| † | K121898 | Stay Fresh Skin Fold Management Textile | 2013 |
| † | K083113 | Acticoat Flex 7 Dressing | 2009 |
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 30 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 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. 2015, 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?
Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations.
OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151186: Stay Fresh Hydrocolloid dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151186
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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