510(k) · Cleared

Cleared

Durafiber AG

K103793510(k) TraditionalCleared May 2, 2011126-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 May 2, 2011 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) and 1 other predicate after a 126-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.

Decided: May 2, 2011
Review: 126 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K914604 (1992). 13 ancestors in all, the oldest K890354 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
This deviceK103793 Durafiber AGSmith & Nephew, Inc. · 2011
Descendant · cites it directly · 0 of its ownK161289 DURAFIBER AgSmith & Nephew Medical Limited · 2016

Most influential descendants

Showing 1 of 1 · See all

K161289DURAFIBER AgSmith & Nephew Medical Limited · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K914604	Mepitel Non-Adherent Silicone Dressing	Molnlycke Clinical Products AB	1992	—
−3	K984371	Mepitel Non Adherent Silicone Dressing	Molnlycke Health Care, Inc.	1999	—
−2	K063271	Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…	Convatec, A Division of E.R. Squibb & Sons, LLC	2007	—
−1	K080383	Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing	Convatec, A Division of E.R. Squibb & Sons, LLC	2008	—
0 (this device)	K103793	Durafiber AG	Smith & Nephew, Inc.	2011	—
+1	K161289	DURAFIBER Ag	Smith & Nephew Medical Limited	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1992	1	0
1994	1	0
1996	1	0
1997	1	0
1998	2	0
2000	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K103793, 1992–2016Source: 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
*	K080383	Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing Summary page 2 …not been implemented by the General and Plastic Surgery Devices Panel. At this time, however, classification code FRO is unclassified. 6. Predicate Device Aquacel Ag (K080383) The DURAFIBER Ag dressing that is the subject of this submission is substantially equivalent to other legally marketed bum and w…	Convatec, A Division of E.R. Squibb & Sons, LLC	2008	—
*	K083113	Acticoat Flex 7 Dressing Summary page 2 …atures and benefits associated with, a fibrous gelling dressing and the added benefit of an antimicrobial dressing. 7. Other Relevant Predicate Device ACTICOAT Flex 7 (K0831 13) The specified silver content of ACTICOAT Flex 7 (K0831 13) is similar to and slightly higher of that of the subject device DURAF…	Smith & Nephew, Inc.	2009	—

Also cleared against K080383: 14 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161289	DURAFIBER Ag	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 19 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
None of the 13 ancestors has a recall.
Of its descendants, K161289 (Smith & Nephew Medical Limited, 2016) has gone furthest, with 0 descendants of its own.
14 other devices also cite its predicate K080383.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of wounds of partial and full thickness wounds including first and second degree burns. Examples of wound types which indicated are:

* Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and sores (partial & full thickness);

* surgical wounds left to heal by secondary intent;

* traumatic wounds;

* wounds that are prone to minor bleeding, such as wounds that have been mechanically or surgically debrided.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103793 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103793: Durafiber AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103793

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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