510(k) · Cleared

Cleared

Antimicrobial Alginate Dressing

K024298510(k) TraditionalCleared Jun 30, 2003188-day reviewClass U

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

Advanced Medical Solutions, Ltd. · FRO Dressing, Wound, Drug

Cleared on Jun 30, 2003 as substantially equivalent to K002896 (The Westaim Corp., 2001) after a 188-day review. Its family tree reaches back 3 generations to 1991. 53 later devices descend from it.

Decided: Jun 30, 2003
Review: 188 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K914575 (1991). 5 ancestors in all. 53 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
2 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
1 generation backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
This deviceK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
Descendant · cites it directly · 25 of its ownK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
Descendant · cites it directly · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
Descendant · 2 generations on · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
Descendant · cites it directly · 7 of its ownK050261 V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2004high 5 (2010) · low 0 (2025)2026

Most influential descendants

Showing 5 of 53 · See all

K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004 · cites it directly25descendants
K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · cites it directly17descendants
K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · 2 generations on11descendants
K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants
K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005 · cites it directly7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K914575	Sorbsan Topical Wound Dressing (Modified)	Dow B. Hickam, Inc.	1991	—
−2	K983210	Algisite M	Smith & Nephew, Inc.	1998	—
−1	K002896	Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing	The Westaim Corp.	2001	—
0 (this device)	K024298	Antimicrobial Alginate Dressing	Advanced Medical Solutions, Ltd.	2003	—
+1	K032986	Clo-Surplusp.a.D.	Scion Cardio-Vascular, Inc.	2004	—
+1	K033869	Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)	Coloplast Corp.	2004	—
+2	K100218	Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM	Coloplast A/S	2010	—
+2	K080818	Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing	Hem Con Medical Technologies, Inc.	2008	—
+1	K050261	V.a.C. Granufoam Silver Protection Dressing	Kinetic Concepts, Inc.	2005	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	1	0
2006	2	0
2007	1	0
2008	2	0
2009	3	0
2010	5	0
2011	1	0
2012	3	0
2013	3	0
2014	1	0
2015	5	0
2016	2	0
2017	2	0
2018	3	0
2019	3	0
2020	2	0
2021	1	0
2022	2	0
2023	4	0
2024	4	0
2026	1	0

FIG. 1 — Lineage of K024298, 1991–2026Source: 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 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? (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
*	K002896	Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing	The Westaim Corp.	2001	—

Also cleared against K002896: 4 other devices →

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K032986	Clo-Surplusp.a.D.	Scion Cardio-Vascular, Inc.	2004	25
K033869	Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)	Coloplast Corp.	2004	17
K050261	V.a.C. Granufoam Silver Protection Dressing	Kinetic Concepts, Inc.	2005	7
K081363	Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial…	Advanced Medical Solutions Limited	2008	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 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K032986 (Scion Cardio-Vascular, Inc., 2004) has gone furthest, with 25 descendants of its own.
4 other devices also cite its predicate K002896.

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?

Advanced Medical Solutions Ltd's Antimicrobial Alginate-Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024298 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024298: Antimicrobial Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024298

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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