510(k) · Cleared

Cleared

Arglaes-AB Antimicrobial Barrier Island Dressing

K973657510(k) TraditionalCleared Dec 1, 199767-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. · MGP Dressing, Wound And Burn, Occlusive

Cleared on Dec 1, 1997 after a 67-day review. The FDA summary names no predicate by number. 43 later devices descend from it.

Decided: Dec 1, 1997
Review: 67 days
Class: Class U
Product code: MGP
Recalls: None
Predicates: 0

43 later devices descend from it, 3 citing it directly.

This deviceK973657 Arglaes-AB Antimicrobial Barrier Island DressingMaersk Medical, Ltd. · 1997
Descendant · cites it directly · 28 of its ownK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
Descendant · cites it directly · 21 of its ownK990530 Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000 · Recalled
Descendant · 2 generations on · 13 of its ownK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
Descendant · 2 generations on · 7 of its ownK070653 Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use…Tyco Healthcare · 2007
Descendant · 3 generations on · 7 of its ownK061220 Urgotul AGLaboratoires Urgo · 2006

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

1999high 4 (2007) · low 0 (2016)2026

Most influential descendants

Showing 5 of 43 · See all

K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999 · cites it directly28descendants
K990530Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000 · cites it directly21descendants
K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp. · 2002 · 2 generations on13descendants
K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · 2 generations on7descendants
K061220Urgotul AGLaboratoires Urgo · 2006 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973657	Arglaes-AB Antimicrobial Barrier Island Dressing	Maersk Medical, Ltd.	1997	—
+1	K990810	Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing	Maersk Medical, Ltd.	1999	—
+1	K990530	Kerlix MD Antimicrobial Gauze Dressing	The Kendall Company, L.P.	2000	7
+2	K013525	Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X…	Coloplast Corp.	2002	—
+2	K070653	Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662	Tyco Healthcare	2007	—
+3	K061220	Urgotul AG	Laboratoires Urgo	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2001	2	0
2002	1	0
2003	1	0
2004	2	0
2005	2	0
2006	3	0
2007	4	0
2008	1	0
2009	1	0
2010	3	0
2011	1	0
2012	3	0
2013	1	0
2014	2	0
2015	2	0
2017	1	0
2018	1	0
2020	1	0
2023	3	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K973657, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K990810	Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing	Maersk Medical, Ltd.	1999	28
K990530	Kerlix MD Antimicrobial Gauze Dressing	The Kendall Company, L.P.	2000	21
K004028	Arglaes-AB Antimicrobial Barrier Powder Dressing	Maersk Medical, Ltd.	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?

Of its descendants, K990810 (Maersk Medical, Ltd., 1999) has gone furthest, with 28 descendants of its own.

How does its category compare?

All MGP devices

MGP 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

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGP

8in 2024

2007high 52 (2021) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	1
2010	—	0	2
2011	—	1	4
2012	—	0	0
2013	—	0	7
2014	—	0	1
2015	—	0	3
2016	—	0	1
2017	—	0	6
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	52
2022	—	0	3
2023	—	0	3
2024	—	0	8
2025	—	0	0
2026	—	0	—

What is it indicated for?

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…

Read the full statement (92 words)

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, for use on individuals with a known sensitivity to silver, and are not intended to be surgically implanted.

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/K973657 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973657: Arglaes-AB Antimicrobial Barrier Island Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973657

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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