510(k) · Cleared

Cleared

Triosyn T40 Antimicrobial Wound Dressing

K051542510(k) TraditionalCleared Mar 17, 2006280-day reviewClass U

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

Triosyn Corp. · FRO Dressing, Wound, Drug

Cleared on Mar 17, 2006 as substantially equivalent to K001519 (Westaim Biomedical, Inc., 2000) and 1 other predicate after a 280-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Mar 17, 2006
Review: 280 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K940414 (1994). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK940414 Iodoflex PasteOclassen Pharmaceuticals, Inc. · 1994
This deviceK051542 Triosyn T40 Antimicrobial Wound DressingTriosyn Corp. · 2006
Descendant · cites it directly · 4 of its ownK063059 Sorbact Wound DressingAbigo Medical AB · 2007
Descendant · 2 generations on · 1 of its ownK143151 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive…Bsn Medical GmbH · 2015
Descendant · 2 generations on · 0 of its ownK171225 Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017
Descendant · 2 generations on · 0 of its ownK153674 Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016
Descendant · 2 generations on · 0 of its ownK100591 SorbactAbigo Medical AB · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007high 1 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all

K063059Sorbact Wound DressingAbigo Medical AB · 2007 · cites it directly4descendants
K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…Bsn Medical GmbH · 2015 · 2 generations on1descendant
K171225Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017 · 2 generations on0descendants
K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016 · 2 generations on0descendants
K100591SorbactAbigo Medical AB · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940414	Iodoflex Paste	Oclassen Pharmaceuticals, Inc.	1994	—
0 (this device)	K051542	Triosyn T40 Antimicrobial Wound Dressing	Triosyn Corp.	2006	—
+1	K063059	Sorbact Wound Dressing	Abigo Medical AB	2007	—
+2	K143151	Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…	Bsn Medical GmbH	2015	—
+2	K171225	Sorbact Wound Dressing-Ribbon Gauze	Abigo Medical AB	2017	—
+2	K153674	Sorbact Foam Gentle Border, Sorbact Superabsorbent	Abigo Medical AB	2016	—
+2	K100591	Sorbact	Abigo Medical AB	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0
2011	1	0
2015	1	0
2016	1	0
2017	1	0

FIG. 1 — Lineage of K051542, 1994–2017Source: 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
*	K001519	Acticoat 7 Dressing Summary page 1 …ressing Classification: Unclassified 8.4. Legally Marketed Predicate Devices Acticoat 7 Composite Wound Dressing (K001 519) lodoflex Paste (K940414) 8.5. Device Description The Triosyn T40"' Antimicrobial W…	Westaim Biomedical, Inc.	2000	—
*	K940414	Iodoflex Paste Summary page 1 …Unclassified 8.4. Legally Marketed Predicate Devices Acticoat 7 Composite Wound Dressing (K001 519) lodoflex Paste (K940414) 8.5. Device Description The Triosyn T40"' Antimicrobial Wound Dressing is a sterile, primary wound…	Oclassen Pharmaceuticals, Inc.	1994	—

Also cleared against K001519: 8 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K063059	Sorbact Wound Dressing	Abigo Medical AB	2007	4
K093320	Dryodine Cadexomer-Iodine Gel	Collegium Pharmaceutical Incorporated	2010	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?

None of the 2 ancestors has a recall.
Of its descendants, K063059 (Abigo Medical AB, 2007) has gone furthest, with 4 descendants of its own.
8 other devices also cite its predicate K001519.

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 Triosyn T40 TM Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. The Triosyn T40T Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051542: Triosyn T40 Antimicrobial 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/K051542

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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