510(k) · Cleared

Cleared

Acticoat Moisture Control Dressing

K050030510(k) TraditionalCleared Apr 21, 2005104-day reviewClass U

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

Smith & Nephew, Inc. · FRO Dressing, Wound, Drug

Cleared on Apr 21, 2005 as substantially equivalent to K000051 (Westaim Biomedical, Inc., 2000) after a 104-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.

Decided: Apr 21, 2005
Review: 104 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000051 (2000). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK000051 Acticoat Foam DressingWestaim Biomedical, Inc. · 2000 · Recalled
This deviceK050030 Acticoat Moisture Control DressingSmith & Nephew, Inc. · 2005
Descendant · cites it directly · 3 of its ownK083133 Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing…Andover Healthcare, Inc. · 2009
Descendant · cites it directly · 3 of its ownK063835 Allevyn AG DressingSmith & Nephew, Inc. · 2007
Descendant · 2 generations on · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
Descendant · 2 generations on · 1 of its ownK110062 Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AGMedipurpose Pte., Ltd. · 2011
Descendant · 3 generations on · 0 of its ownK242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON®…Huizhou Foryou Medical Devices Co., Ltd. · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007high 2 (2009) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all

K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc. · 2009 · cites it directly3descendants
K063835Allevyn AG DressingSmith & Nephew, Inc. · 2007 · cites it directly3descendants
K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · 2 generations on1descendant
K110062Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AGMedipurpose Pte., Ltd. · 2011 · 2 generations on1descendant
K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000051	Acticoat Foam Dressing	Westaim Biomedical, Inc.	2000	1
0 (this device)	K050030	Acticoat Moisture Control Dressing	Smith & Nephew, Inc.	2005	—
+1	K083133	Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex…	Andover Healthcare, Inc.	2009	—
+1	K063835	Allevyn AG Dressing	Smith & Nephew, Inc.	2007	—
+2	K223360	LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial…	Huizhou Foryou Medical Devices Co., Ltd.	2024	—
+2	K110062	Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AG	Medipurpose Pte., Ltd.	2011	—
+3	K242856	LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone…	Huizhou Foryou Medical Devices Co., Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	2	0
2011	1	0
2015	1	0
2016	1	0
2023	1	0
2024	2	0

FIG. 1 — Lineage of K050030, 2000–2024Source: 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? (1)

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
*	K000051	Acticoat Foam Dressing Summary page 2 …ied by a process known as physical vapor deposition which is identical manufacturing process approved for use in the manufacture of the predicate device Acticoat Foam (K000051). The same process is also approved as the method for…	Westaim Biomedical, Inc.	2000	1
†	K963096	Allevyn Hydro Poly Dressing ND All Trac Dressing	Smith & Nephew United, Inc.	1996	—
†	K973260	Hydrasorb Sterile Dressing	Avitar, Inc.	1997	—
†	K010447	Modification to Acticoat Foam Dressing	Westaim Biomedical, Inc.	2001	—
†	K001519	Acticoat 7 Dressing	Westaim Biomedical, Inc.	2000	—
†	K002896	Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing	The Westaim Corp.	2001	—

Also cleared against K000051: 2 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K083133	Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…	Andover Healthcare, Inc.	2009	3
K063835	Allevyn AG Dressing	Smith & Nephew, Inc.	2007	3
K153723	ACTICOAT Surgical Dressing	Smith & Nephew Medical Limited	2016	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?

Its one ancestor has a recall.
Of its descendants, K083133 (Andover Healthcare, Inc., 2009) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K000051.

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 Acticoat® Moisture Control Dressing is indication for use in light to moderately exuding partial thickness wounds including decubitus ulcers, 1st and 2 nd degree bums, and donor sites.

Acticoat Moisture Control may be used over debrided and partial thickness wounds

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050030 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050030: Acticoat Moisture Control Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050030

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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