510(k) · Cleared

Cleared

Urgotul AG

K061220510(k) TraditionalCleared Jul 27, 200687-day reviewClass U

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

Laboratoires Urgo · FRO Dressing, Wound, Drug

Cleared on Jul 27, 2006 as substantially equivalent to K013525 (Coloplast Corp., 2002) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 1997. 7 later devices descend from it.

Decided: Jul 27, 2006
Review: 87 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K970566 (1997). 6 ancestors in all, the oldest K941263 (1994). 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
2 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
1 generation backK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
This deviceK061220 Urgotul AGLaboratoires Urgo · 2006
Descendant · cites it directly · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
Descendant · cites it directly · 2 of its ownK100430 Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010
Descendant · 2 generations on · 1 of its ownK072378 Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and…Arthrex, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK242758 Atrauman® AgHartmann USA, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK130040 Mepitel AGMolnlycke Health Care · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all

K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · cites it directly6descendants
K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010 · cites it directly2descendants
K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc. · 2007 · 2 generations on1descendant
K242758Atrauman® AgHartmann USA, Inc. · 2024 · 2 generations on0descendants
K130040Mepitel AGMolnlycke Health Care · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K970566	Arglaes Film Dressing	Maersk Medical, Ltd.	1997	—
−2	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	—
0 (this device)	K061220	Urgotul AG	Laboratoires Urgo	2006	—
+1	K062559	Urgocell AG Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2007	—
+1	K100430	Urgotul AG, Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2010	—
+2	K072378	Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models…	Arthrex, Inc.	2007	—
+2	K242758	Atrauman® Ag	Hartmann USA, Inc.	2024	—
+2	K130040	Mepitel AG	Molnlycke Health Care	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	1	0
2010	2	0
2014	1	0
2024	1	0

FIG. 1 — Lineage of K061220, 1997–2024Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K013525	Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613… Summary page 1 …e: Urgotull® Ag Classification Name: Unclassified 3. Predicate Devices: Contreet-H Antibacterial Hydrocolloid Dressing (K013525), Coloplast Corp. Acticoat-7 Dressing (KO015 19), Smith & Nephew 4. Description of Device Urgotul®~ A…	Coloplast Corp.	2002	—
*	K001519	Acticoat 7 Dressing	Westaim Biomedical, Inc.	2000	—

Also cleared against K013525: 3 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K062559	Urgocell AG Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2007	6
K100430	Urgotul AG, Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2010	2
K100429	Urgocell AG, Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2010	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?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K062559 (Laboratoires Urgo, 2007) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K013525.

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

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

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

Recalls per year · FRO

2in 2024

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

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

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?

The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061220: Urgotul AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061220

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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