510(k) · Cleared

Cleared

Urgoclean Absorbent Wound Dressing

K123219510(k) TraditionalCleared Mar 18, 2013154-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 Mar 18, 2013 as substantially equivalent to K982116 (Convatec, A Bristol-Myers Squibb Co., 1998) and 2 other predicates after a 154-day review. Its family tree reaches back 4 generations to 1992.

Decided: Mar 18, 2013
Review: 154 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K914604 (1992). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
This deviceK123219 Urgoclean Absorbent Wound DressingLaboratoires Urgo · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K914604	Mepitel Non-Adherent Silicone Dressing	Molnlycke Clinical Products AB	1992	—
−3	K984371	Mepitel Non Adherent Silicone Dressing	Molnlycke Health Care, Inc.	1999	—
−2	K063271	Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…	Convatec, A Division of E.R. Squibb & Sons, LLC	2007	—
−1	K080383	Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing	Convatec, A Division of E.R. Squibb & Sons, LLC	2008	—
0 (this device)	K123219	Urgoclean Absorbent Wound Dressing	Laboratoires Urgo	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1998	1	0

FIG. 1 — Lineage of K123219, 1992–2013Source: 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

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What was it cleared against? (3)

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
*	K982116	Aquacel Hydrofiber Wound Dressing Summary page 1 …y Name: Urgoclean Absorbent Wound Dressing Classification Name: Dressing, Wound, Hydrophilic 3. Predicate Devices: AquaceIl'Hydrofiber®O Wound Dressing (K9821 16, K063271,.K080383), Convatec. 4. Description of Device Urgoclean Absorbent Wound Dressing is a sterile non-woven highly…	Convatec, A Bristol-Myers Squibb Co.	1998	—
*	K063271	Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… Summary page 1 …Urgoclean Absorbent Wound Dressing Classification Name: Dressing, Wound, Hydrophilic 3. Predicate Devices: AquaceIl'Hydrofiber®O Wound Dressing (K9821 16, K063271,.K080383), Convatec. 4. Description of Device Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent…	Convatec, A Division of E.R. Squibb & Sons, LLC	2007	—
*	K080383	Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing Summary page 1 …an Absorbent Wound Dressing Classification Name: Dressing, Wound, Hydrophilic 3. Predicate Devices: AquaceIl'Hydrofiber®O Wound Dressing (K9821 16, K063271,.K080383), Convatec. 4. Description of Device Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent pad…	Convatec, A Division of E.R. Squibb & Sons, LLC	2008	—

Also cleared against K982116: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
None of the 6 ancestors has a recall.
2 other devices also cite its predicate K982116.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

Urgoclean Absorbent Wound Dressing is indicated to manage all exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage ll-IV), diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological); partial thickness bums; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123219: Urgoclean Absorbent Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123219

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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