510(k) · Cleared
ClearedHydrocolloid Dressings - Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Division of E.R. Squibb & Sons · FRO Dressing, Wound, Drug
Cleared on Sep 30, 1986 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 30, 1986
- Review
- 27 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK863390 Hydrocolloid Dressings - SterileConvatec, A Division of E.R. Squibb & Sons · 1986
- Descendant · cites it directly · 4 of its ownK983249 Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK992363 Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK081274 Sureskin Silver BandagesEuromed, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK151186 Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K983249Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998 · cites it directly4descendants
- K992363Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc. · 1999 · cites it directly3descendants
- K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006 · 2 generations on2descendants
- K081274Sureskin Silver BandagesEuromed, Inc. · 2008 · 3 generations on1descendant
- K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863390 | Hydrocolloid Dressings - Sterile | Convatec, A Division of E.R. Squibb & Sons | 1986 | — |
| +1 | 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 | — |
| +2 | K050032 | Euromed Sureskin Iii with Silver Wound Dressings | Euromed, Inc. | 2006 | — |
| +3 | K081274 | Sureskin Silver Bandages | Euromed, Inc. | 2008 | — |
| +3 | K151186 | Stay Fresh Hydrocolloid dressing | Sarasota Medical Products, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K983249 (Euromed, Inc., 1998) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K863390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K863390: Hydrocolloid Dressings - Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863390
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026