510(k) · Cleared

Cleared

Acticoat Flex 7 Dressing

K083113510(k) TraditionalCleared Jul 22, 2009274-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 Jul 22, 2009 as substantially equivalent to K981299 (Argentum International, LLC, 1998) and 1 other predicate after a 274-day review. Its family tree reaches back 3 generations to 1992. 22 later devices descend from it.

Decided: Jul 22, 2009
Review: 274 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K914579 (1992). 6 ancestors in all, the oldest K890354 (1989). 22 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
2 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
1 generation backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
This deviceK083113 Acticoat Flex 7 DressingSmith & Nephew, Inc. · 2009
Descendant · cites it directly · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
Descendant · 2 generations on · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
Descendant · 2 generations on · 4 of its ownK150256 Silverlon Burn Contact DressingsArgentum Medical · 2015
Descendant · cites it directly · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
Descendant · 2 generations on · 3 of its ownK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2011high 5 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 22 · See all

K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · cites it directly13descendants
K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · 2 generations on5descendants
K150256Silverlon Burn Contact DressingsArgentum Medical · 2015 · 2 generations on4descendants
K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · cites it directly4descendants
K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K914579	Silver Foam Wound Dressing	Vitaphore Corp.	1992	—
−2	K955453	Acticoat Silver Coated Dressing	Westaim Technologies, Inc.	1996	—
−1	K981299	Silverlon Contact Wound Dressing	Argentum International, LLC	1998	—
0 (this device)	K083113	Acticoat Flex 7 Dressing	Smith & Nephew, Inc.	2009	—
+1	K122817	Silverlon Island Wound Dressing	Argentum Medical, LLC	2014	—
+2	K143001	Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing	Argentum Medical	2014	—
+2	K150256	Silverlon Burn Contact Dressings	Argentum Medical	2015	—
+1	K123961	Sentrex Biosponge MPD	Bionova Medical, Inc.	2013	—
+2	K210949	Foundation Dermal Regeneration Scaffold (DRS) Solo	Bionova Medical, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2014	4	0
2015	1	0
2016	2	0
2018	2	0
2019	2	0
2022	2	0
2023	2	0
2024	5	0

FIG. 1 — Lineage of K083113, 1992–2024Source: 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

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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
*	K981299	Silverlon Contact Wound Dressing Summary page 2 …s not been implemented by the General and Plastic Surgery Devices Panel. At this time, however, classification code FRO is unclassified. 6. Predicate Device Silvelon (K981299). The ACTICOAT FLEX 7 dressing cover by this submission is substantial equivalent to other legally marketed bum and wound dressi…	Argentum International, LLC	1998	—
*	K001519	Acticoat 7 Dressing	Westaim Biomedical, Inc.	2000	—

Also cleared against K981299: 12 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K122817	Silverlon Island Wound Dressing	Argentum Medical, LLC	2014	13
K123961	Sentrex Biosponge MPD	Bionova Medical, Inc.	2013	4
K103793	Durafiber AG	Smith & Nephew, Inc.	2011	1
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?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K122817 (Argentum Medical, LLC, 2014) has gone furthest, with 13 descendants of its own.
12 other devices also cite its predicate K981299.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

ACTICOAT FLEX 7 is indicated for use on partial and full thickness wounds for up to 7 days.

This includes: first and second-degree bums, as a protective covering of grafts, surgical sites, venous ulcers, pressure ulcers, diabetic ulcers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083113: Acticoat Flex 7 Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083113

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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