510(k) · Cleared
ClearedSilverlon Island Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argentum Medical · FRO Dressing, Wound, Drug
Cleared on Aug 28, 2014 as substantially equivalent to K122817 (Argentum Medical, LLC, 2014) after a 77-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Aug 28, 2014
- Review
- 77 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914579 (1992). 16 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
- 1 generation backK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
- This deviceK141573 Silverlon Island Wound DressingArgentum Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K984208 | Silverlon Island Dressing, Silverlon Island Pad | Argentum International, LLC | 1999 | — |
| −1 | K122817 | Silverlon Island Wound Dressing | Argentum Medical, LLC | 2014 | — |
| 0 (this device) | K141573 | Silverlon Island Wound Dressing | Argentum Medical | 2014 | — |
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 |
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
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 | Decided |
|---|---|---|---|
| * | K122817 | Silverlon Island Wound DressingSummary page 5…Pre-Amendment 21 CFR Number: None Product code: FRO 5.7. Substantially Equivalent Devices (Predicates): Predicate: SILVERLON ISLAND WOUND DRESSING (K122817) 2014-08-25 Page 1 of 4… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 16 ancestors has a recall.
- 3 other devices also cite its predicate K122817.
How does its category compare?
All FRO devicesFRO 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 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® Island Wound Dressing is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Prescription Indications: 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 1V sites, orthopedic external pin…
Read the full statement (188 words)
Silverlon® Island Wound Dressing is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Prescription Indications:
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 1V sites, orthopedic external pin sites, wound drain sites, surgical
wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-1V pressure sores, venous
stasis ulcers, arterial ulcers, diabetic ulcers).
Silverlon® 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.
Silverlon® Island Wound Dressing may be used for the management of painful wounds, Silverlon® Island Wound
Dressing’s non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the
dressing may soothe the wound.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141573 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141573: Silverlon Island Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141573
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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