510(k) · Cleared
ClearedArglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maersk Medical, Ltd. · FRO Dressing, Wound, Drug
Cleared on Sep 17, 1999 as substantially equivalent to K970566 (Maersk Medical, Ltd., 1997) and 1 other predicate after a 190-day review. Its family tree reaches back 1 generation to 1997. 28 later devices descend from it.
- Decided
- Sep 17, 1999
- Review
- 190 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970566 (1997). 2 ancestors in all. 28 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- This deviceK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- Descendant · cites it directly · 13 of its ownK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
- Descendant · 2 generations on · 7 of its ownK061220 Urgotul AGLaboratoires Urgo · 2006
- Descendant · cites it directly · 7 of its ownK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- Descendant · 3 generations on · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- Descendant · cites it directly · 3 of its ownK121819 Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with…Covalontechnologies, Inc. · 2012
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp. · 2002 · cites it directly13descendants
- K061220Urgotul AGLaboratoires Urgo · 2006 · 2 generations on7descendants
- K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 2003 · cites it directly7descendants
- K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · 3 generations on6descendants
- K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| 0 (this device) | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| +1 | K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X… | Coloplast Corp. | 2002 | — |
| +2 | K061220 | Urgotul AG | Laboratoires Urgo | 2006 | — |
| +1 | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| +3 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| +1 | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine… | Covalontechnologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K970566 | Arglaes Film DressingSummary page 2…mmon / usual name Topical wound Dressing Proprietary hames ARGLAES-AB™ Antimicrobial Barrier Film and Island Dressings ARGLAES-AB™ Antimicrobial Barrier Film Dressing (K970566) ARGLAES-AB™ Antimicrobial Barrier Island Dressing (K973657) ARGLAES-AB™ Antimicrobial Barrier Film Dressings are sterile, visua… | 1997 |
| * | K973657 | Arglaes-AB Antimicrobial Barrier Island DressingSummary page 2…RGLAES-AB™ Antimicrobial Barrier Film and Island Dressings ARGLAES-AB™ Antimicrobial Barrier Film Dressing (K970566) ARGLAES-AB™ Antimicrobial Barrier Island Dressing (K973657) ARGLAES-AB™ Antimicrobial Barrier Film Dressings are sterile, visually clear, oxygen and moisture vapor permeable, and self-adh… | 1997 |
What descends from it? (28)
See all 288 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613… | 2002 | 13 |
| K024054 | Xylos Xcell Antimicrobial Dressing | 2003 | 7 |
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 3 |
| K033900 | X-Static Silverseal Hydrocolloid Film and Island Dressing | 2005 | 2 |
| K041268 | Silversite or Calgitrol | 2004 | 2 |
| K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 0 |
| K033453 | Kendall Ultec Pro AG+ Hydrocolloid Dressing | 2004 | 0 |
| K004028 | Arglaes-AB Antimicrobial Barrier Powder Dressing | 2001 | 0 |
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?
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 | — |
What is it indicated for?
ARGLAES-AB Antimicrobial 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-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters. ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a…
Read the full statement (133 words)
ARGLAES-AB Antimicrobial 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-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters.
ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing.
ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected:
Pressure Ulcers
Venous Ulcers
Diabetic Ulcers
Arterial Ulcers
Donor Sites and other bleeding surface wounds
Dermal lesions, trauma injuries or incisions.
ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns or for use on individuals with a known sensitivity to silver.
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/K990810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990810
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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