510(k) Report

510(k) · Cleared

Cleared

Sureskin II Standard, Sureskin II Border, Sureskin II Thin

K992363510(k) SpecialCleared Aug 12, 199928-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Euromed, Inc. · FRO Dressing, Wound, Drug

Cleared on Aug 12, 1999 as substantially equivalent to K983249 (Euromed, Inc., 1998) and 4 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.

Decided
Aug 12, 1999
Review
28 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K853844 (1985). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 3 other ancestors1986: 1 other ancestor2006: 1 descendant cleared2008: 1 descendant cleared2015: 1 descendant clearedK853844 · Duoderm Hydroactive Dressing W/Border Sterile · Convatec, A Division of E.R. Squibb & Sons · 1985K983249 · Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin · Euromed, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K983249 · Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin · Euromed, Inc. · 1998K853844 · Duoderm Hydroactive Dressing W/Border Sterile · Convatec, A Division of E.R. Squibb & Sons · 19850
  1. Root · 2 generations backK853844 Duoderm Hydroactive Dressing W/Border SterileConvatec, A Division of E.R. Squibb & Sons · 1985
  2. 1 generation backK983249 Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998
  3. This deviceK992363 Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc. · 1999
  4. Descendant · cites it directly · 2 of its ownK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
  5. Descendant · 2 generations on · 1 of its ownK081274 Sureskin Silver BandagesEuromed, Inc. · 2008
  6. Descendant · 2 generations on · 0 of its ownK151186 Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006 · cites it directly2descendants
  • K081274Sureskin Silver BandagesEuromed, Inc. · 2008 · 2 generations on1descendant
  • K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K853844Duoderm Hydroactive Dressing W/Border SterileConvatec, A Division of E.R. Squibb & Sons1985—
−1K983249Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc.1998—
0 (this device)K992363Sureskin II Standard, Sureskin II Border, Sureskin II ThinEuromed, Inc.1999—
+1K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.2006—
+2K081274Sureskin Silver BandagesEuromed, Inc.2008—
+2K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201510
FIG. 1 — Lineage of K992363, 1985–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K983249Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin
Summary page 1
…Name: SureSkin™ II Common/Usual Name: Hydrocolloid Wound Dressing Classification Name: Occlusive Wound and Burn Dressing 3. PREDICATE DEVICES % SureSkin™ Plus Dressing K983249 SureSkin™ BORDER Dressing K960393 SureSkin™ STANDARD Dressing K960394 SureSkin™ THIN Dressing K960404 DuoDerm Dressings by Convat…
Euromed, Inc.1998—
*K960393Sureskin Border
Summary page 1
…me: Hydrocolloid Wound Dressing Classification Name: Occlusive Wound and Burn Dressing 3. PREDICATE DEVICES % SureSkin™ Plus Dressing K983249 SureSkin™ BORDER Dressing K960393 SureSkin™ STANDARD Dressing K960394 SureSkin™ THIN Dressing K960404 DuoDerm Dressings by Convatec ~ K863390 4, DEVICE DESCRIPTIO…
Euromed A/S1996—
*K960394Sureskin Standard
Summary page 1
…sification Name: Occlusive Wound and Burn Dressing 3. PREDICATE DEVICES % SureSkin™ Plus Dressing K983249 SureSkin™ BORDER Dressing K960393 SureSkin™ STANDARD Dressing K960394 SureSkin™ THIN Dressing K960404 DuoDerm Dressings by Convatec ~ K863390 4, DEVICE DESCRIPTION The SureSkin II wound dressings a…
Euromed A/S1996—
*K960404Sureskin Thin
Summary page 1
…and Burn Dressing 3. PREDICATE DEVICES % SureSkin™ Plus Dressing K983249 SureSkin™ BORDER Dressing K960393 SureSkin™ STANDARD Dressing K960394 SureSkin™ THIN Dressing K960404 DuoDerm Dressings by Convatec ~ K863390 4, DEVICE DESCRIPTION The SureSkin II wound dressings are identical to the SureSkin Plu…
Euromed A/S1996—
*K863390Hydrocolloid Dressings - Sterile
Summary page 1
…% SureSkin™ Plus Dressing K983249 SureSkin™ BORDER Dressing K960393 SureSkin™ STANDARD Dressing K960394 SureSkin™ THIN Dressing K960404 DuoDerm Dressings by Convatec ~ K863390 4, DEVICE DESCRIPTION The SureSkin II wound dressings are identical to the SureSkin Plus products with the exception that the f…
Convatec, A Division of E.R. Squibb & Sons1986—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062

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 14 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K050032 (Euromed, Inc., 2006) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

The SureSkin II STANDARD and SureSkin II BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.

The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers; post-operative wounds, superficial wounds and abrasions.

The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Euromed, Inc.

4 FDA decisions under this applicant name. See the company

  • K081274Sureskin Silver BandagesEuromed, Inc. · 2008
  • K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
  • K983249Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus ThinEuromed, Inc. · 1998

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K992363 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992363: Sureskin II Standard, Sureskin II Border, Sureskin II Thin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992363

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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