510(k) Report

510(k) · Cleared

Cleared

Arglaes Film Dressing

K970566510(k) TraditionalCleared Jul 29, 1997166-day reviewClass U

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

Maersk Medical, Ltd. · FRO Dressing, Wound, Drug

Cleared on Jul 29, 1997 after a 166-day review. The FDA summary names no predicate by number. 177 later devices descend from it.

Decided
Jul 29, 1997
Review
166 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

177 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 7 descendants cleared1999: 3 descendants cleared1998: 1 descendant cleared2001: 1 descendant cleared2005: 5 descendants cleared2007: 6 descendants cleared2018: 8 descendants cleared2011: 5 descendants cleared2003: 3 descendants cleared2006: 4 descendants cleared2014: 14 descendants cleared2009: 11 descendants cleared2016: 8 descendants cleared2008: 4 descendants cleared2012: 5 descendants cleared2002: 1 descendant cleared2010: 10 descendants cleared2013: 5 descendants cleared2015: 10 descendants cleared2017: 8 descendants cleared2024: 12 descendants cleared2026: 14 descendants cleared2023: 8 descendants cleared2022: 7 descendants cleared2019: 5 descendants cleared2025: 5 descendants cleared2020: 4 descendants cleared2021: 3 descendants cleared1995200020052010201520202025
  1. This deviceK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
  2. Descendant · cites it directly · 149 of its ownK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
  3. Descendant · 2 generations on · 102 of its ownK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
  4. Descendant · 3 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
  5. Descendant · 4 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
  6. Descendant · 5 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled

Showing 5 of 177 descendants. See all descendants

Descendants cleared per year

1998: 11999: 32001: 12002: 12003: 32004: 72005: 52006: 42007: 62008: 42009: 112010: 102011: 52012: 52013: 52014: 142015: 102016: 82017: 82018: 82019: 52020: 42021: 32022: 72023: 82024: 122025: 52026: 14
1998high 14 (2014) · low 0 (2000)2026

Most influential descendants

Showing 5 of 177 · See all
  • K981299Silverlon Contact Wound DressingArgentum International, LLC · 1998 · cites it directly149descendants
  • K023612Silverlon Contact Wound DressingArgentum International, LLC · 2003 · 2 generations on102descendants
  • K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 3 generations on73descendants
  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 4 generations on66descendants
  • K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 5 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970566Arglaes Film DressingMaersk Medical, Ltd.1997—
+1K981299Silverlon Contact Wound DressingArgentum International, LLC1998—
+2K023612Silverlon Contact Wound DressingArgentum International, LLC2003—
+3K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC2007—
+4K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and…Anacapa Technologies, Inc.2008—
+5K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.20093

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199930
200110
200210
200330
200470
200550
200640
200760
200840
2009110
2010100
201150
201250
201350
2014140
2015100
201680
201780
201880
201950
202040
202130
202270
202380
2024120
202550
2026140
FIG. 1 — Lineage of K970566, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (177)

See all 177

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981299Silverlon Contact Wound DressingArgentum International, LLC1998149
K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd.199928
K033587SilversealNoble Fiber Technologies20049
K041268Silversite or CalgitrolAdri20042
K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd.20010

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, K981299 (Argentum International, LLC, 1998) has gone furthest, with 149 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?

ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers.

ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.

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

More from Maersk Medical, Ltd.

4 FDA decisions under this applicant name. See the company

  • K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd. · 2001
  • K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
  • K973657Arglaes-AB Antimicrobial Barrier Island DressingMaersk Medical, Ltd. · 1997

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/K970566 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970566: Arglaes Film Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970566

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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