510(k) · Cleared

Cleared

Colactive AG Collagen with Silver Antimicrobial Dressing

K043296510(k) TraditionalCleared Jun 6, 2005189-day reviewClass U

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

Covalontechnologies, Inc. · FRO Dressing, Wound, Drug

Cleared on Jun 6, 2005 after a 189-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided: Jun 6, 2005
Review: 189 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 0

13 later devices descend from it, 2 citing it directly.

This deviceK043296 Colactive AG Collagen with Silver Antimicrobial DressingCovalontechnologies, Inc. · 2005
Descendant · cites it directly · 6 of its ownK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
Descendant · cites it directly · 5 of its ownK052696 Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006
Descendant · 2 generations on · 4 of its ownK120605 Permacol Surgical ImplantCovidien, LLC · 2012
Descendant · 2 generations on · 4 of its ownK063059 Sorbact Wound DressingAbigo Medical AB · 2007
Descendant · 3 generations on · 1 of its ownK160181 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006high 3 (2017) · low 0 (2008)2026

Most influential descendants

Showing 5 of 13 · See all

K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · cites it directly6descendants
K052696Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006 · cites it directly5descendants
K120605Permacol Surgical ImplantCovidien, LLC · 2012 · 2 generations on4descendants
K063059Sorbact Wound DressingAbigo Medical AB · 2007 · 2 generations on4descendants
K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K043296	Colactive AG Collagen with Silver Antimicrobial Dressing	Covalontechnologies, Inc.	2005	—
+1	K100261	Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold	Tei Biosciences, Inc.	2010	3
+1	K052696	Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing	Covalon Technologies, Ltd.	2006	—
+2	K120605	Permacol Surgical Implant	Covidien, LLC	2012	—
+2	K063059	Sorbact Wound Dressing	Abigo Medical AB	2007	—
+3	K160181	Colorado Therapeutics Xenograft Implant	Colorado Therapeutics, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2010	1	0
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2016	2	0
2017	3	0
2018	1	0

FIG. 1 — Lineage of K043296, 2005–2018Source: 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? (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	Recalls
*	—	FIBRACOL PLUS Collagen Wound Dressing with Alginate Named without a submission number	—
*	—	Vitaphore Silver Foam Wound Dressing Named without a submission number	—
*	—	Acticoat Silver Coated Dressing Named without a submission number	—

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K100261	Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold	Tei Biosciences, Inc.	2010	6
K052696	Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing	Covalon Technologies, Ltd.	2006	5

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?

Of its descendants, K100261 (Tei Biosciences, Inc., 2010) has gone furthest, with 6 descendants of its own.

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?

ColActive Ag T Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness including:

* Pressure ulcers

* Diabetic ulcers

* Ulcers caused by mixed vascular etiologies

* Venous ulcers

* First and Second degree bums

* Donor and graft sites

* Abrasions & lacerations

* Dehisced surgical wounds

* Traumatic wounds healing by secondary intention

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043296 · printed Nov 3, 2026

Cite this page

510(k) Report. “K043296: Colactive AG Collagen with Silver Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043296

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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