510(k) · Cleared

Cleared

Silverlon Island Wound Dressing

K122817510(k) TraditionalCleared May 1, 2014594-day reviewClass U

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

Argentum Medical, LLC · FRO Dressing, Wound, Drug

Cleared on May 1, 2014 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) and 2 other predicates after a 594-day review. Its family tree reaches back 4 generations to 1992. 13 later devices descend from it.

Decided: May 1, 2014
Review: 594 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K914579 (1992). 15 ancestors in all, the oldest K890354 (1989). 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
1 generation backK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
This deviceK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
Descendant · cites it directly · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
Descendant · cites it directly · 4 of its ownK150256 Silverlon Burn Contact DressingsArgentum Medical · 2015
Descendant · 2 generations on · 3 of its ownK190343 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019
Descendant · 3 generations on · 1 of its ownK221218 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022
Descendant · 2 generations on · 1 of its ownK180570 Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also…Argentum Medical, LLC · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2014high 3 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all

K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · cites it directly5descendants
K150256Silverlon Burn Contact DressingsArgentum Medical · 2015 · cites it directly4descendants
K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019 · 2 generations on3descendants
K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022 · 3 generations on1descendant
K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC · 2019 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K914579	Silver Foam Wound Dressing	Vitaphore Corp.	1992	—
−3	K955453	Acticoat Silver Coated Dressing	Westaim Technologies, Inc.	1996	—
−2	K981299	Silverlon Contact Wound Dressing	Argentum International, LLC	1998	—
−1	K984208	Silverlon Island Dressing, Silverlon Island Pad	Argentum International, LLC	1999	—
0 (this device)	K122817	Silverlon Island Wound Dressing	Argentum Medical, LLC	2014	—
+1	K143001	Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing	Argentum Medical	2014	—
+1	K150256	Silverlon Burn Contact Dressings	Argentum Medical	2015	—
+2	K190343	Silverlon Wound Contact, Burn Contact Dressings	Argentum Medical, LLC	2019	—
+3	K221218	Silverlon Wound Contact, Burn Contact Dressings	Argentum Medical, Inc.	2022	—
+2	K180570	Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as…	Argentum Medical, LLC	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1992	1	0
1994	1	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2007	1	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	3	0
2015	1	0
2018	2	0
2019	2	0
2022	1	0
2023	1	0
2024	3	0

FIG. 1 — Lineage of K122817, 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

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	Applicant	Decided	Recalls
*	K080383	Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing Summary page 1 …FRO 5.7. Substantially Equivalent Devices (Predicates): Primary Predicate: AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K0803 83) cleared 05/02/2008 PageS8 of 15 S…	Convatec, A Division of E.R. Squibb & Sons, LLC	2008	—
*	K083113	Acticoat Flex 7 Dressing Summary page 2 …PageS8 of 15 SUMMARY STATEMENT (1(122817), page 2. Other predicates: ACTICOAT FLEX 7 DRESSING (K083 113) cleared 07/22/2009 Silverlon Island Wound Dressing and Silverlon Island Pad (K984208) cleared 02/22/1999 5.8. Descript…	Smith & Nephew, Inc.	2009	—
*	K984208	Silverlon Island Dressing, Silverlon Island Pad Summary page 2 …122817), page 2. Other predicates: ACTICOAT FLEX 7 DRESSING (K083 113) cleared 07/22/2009 Silverlon Island Wound Dressing and Silverlon Island Pad (K984208) cleared 02/22/1999 5.8. Description of Device Silverlon®W Island Wound Dressing isa self-adhesive, elastomeric wound…	Argentum International, LLC	1999	—

Also cleared against K080383: 14 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K143001	Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing	Argentum Medical	2014	5
K150256	Silverlon Burn Contact Dressings	Argentum Medical	2015	4
K141033	Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…	Argentum Medical, LLC	2014	0
K141573	Silverlon Island Wound Dressing	Argentum Medical	2014	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 22 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
None of the 15 ancestors has a recall.
Of its descendants, K143001 (Argentum Medical, 2014) has gone furthest, with 5 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. 2014, 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?

Silverlon®D Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing. The Over-The-Counter Indications: Local management of superficial wounds, minor bums, abrasions and lacerations. Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites…

Read the full statement (196 words)

Silverlon®D Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.

The Over-The-Counter Indications:

Local management of superficial wounds, minor bums, abrasions and lacerations.

Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness denmal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlong Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process.

SilverlonS Island Wound Dressing may be used for the management of painful wounds' Silverlon®D Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.

'Clarified/New Indication, not previously included in this format under K984208.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122817: Silverlon Island 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/K122817

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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