510(k) · Cleared
ClearedSilverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argentum Medical, LLC · FRO Dressing, Wound, Drug
Cleared on Jan 14, 2019 as substantially equivalent to K143001 (Argentum Medical, 2014) after a 315-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Jan 14, 2019
- Review
- 315 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914579 (1992). 17 ancestors in all, the oldest K890354 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
- 2 generations backK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
- 1 generation backK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
- This deviceK180570 Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also…Argentum Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK221754 Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive…Winner Medical Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K984208 | Silverlon Island Dressing, Silverlon Island Pad | Argentum International, LLC | 1999 | — |
| −2 | K122817 | Silverlon Island Wound Dressing | Argentum Medical, LLC | 2014 | — |
| −1 | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing | Argentum Medical | 2014 | — |
| 0 (this device) | K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as… | Argentum Medical, LLC | 2019 | — |
| +1 | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone… | Winner Medical Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad DressingSummary page 5…mendment 21 CFR Number: None Product code: FRO 7.0 Substantially Equivalent Devices (Predicate Devices): Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (K143001) 7.1. Reference Device: Silverlon Island Wound Dressing (K122817) 8.0 Device Description Silverlon Island Wound Dressing is a s… | 2014 |
| † | K122817 | Silverlon Island Wound Dressing | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam… | 2023 | 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 27 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K221754 (Winner Medical Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143001.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings. 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 and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as…
Read the full statement (217 words)
Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.
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 and Silverlon® Wound Pad 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 full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are 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 and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad 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 as stated in the FDA summary.
https://510kreport.com/device/K180570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180570: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180570
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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