510(k) · Cleared
ClearedSureskin Thin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euromed A/S · MGP Dressing, Wound And Burn, Occlusive
Cleared on Mar 1, 1996 after a 32-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 1, 1996
- Review
- 32 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK960404 Sureskin ThinEuromed A/S · 1996
- 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) | K960404 | Sureskin Thin | Euromed A/S | 1996 | — |
| +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), 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 MGP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | DuoDERM Extra Thin Flexible Hydrocolloid Dressing Named without a submission number |
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 MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SureSkin® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960404: Sureskin Thin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960404
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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