510(k) · Cleared
ClearedSilverlon® Wound Contact, Burn Contact 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 Jul 31, 2024 as substantially equivalent to K221218 (Argentum Medical, Inc., 2022) after a 90-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jul 31, 2024
- Review
- 90 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K914579 (1992). 28 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 6 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 5 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 4 generations backK073213 Therabond Antimicrobial Barrier SystemsChoice Therapeutics · 2008
- 3 generations backK150256 Silverlon Burn Contact DressingsArgentum Medical · 2015
- 2 generations backK190343 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019
- 1 generation backK221218 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022
- This deviceK241225 Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −7 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −6 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −5 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −4 | K073213 | Therabond Antimicrobial Barrier Systems | Choice Therapeutics | 2008 | — |
| −3 | K150256 | Silverlon Burn Contact Dressings | Argentum Medical | 2015 | — |
| −2 | K190343 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, LLC | 2019 | — |
| −1 | K221218 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, Inc. | 2022 | — |
| 0 (this device) | K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K221218 | Silverlon Wound Contact, Burn Contact DressingsSummary page 5…de: FRO Panel: General & Plastic Surgery III. PREDICATE DEVICE Silverlon® Wound Contact, Burn Contact Dressings, K221218 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2022 |
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 32 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- None of the 28 ancestors has a recall.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Local management of superficial wounds, minor burns, abrasions and lacerations. Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds, surgical wounds (donor and graft sites, incisions), first and second-degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or…
Read the full statement (259 words)
Local management of superficial wounds, minor burns, abrasions and lacerations.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds, surgical wounds (donor and graft sites, incisions), first and second-degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites, and wound drain sites.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first- and second-degree mustard-induced vesicant injuries not requiring skin grafting.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for acute cutaneous radiation injury including moist desquamation without full thickness skin ulceration and/or necrosis.
Silverlon® Wound Contact, Burn Contact 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® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that 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/K241225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241225: Silverlon® Wound Contact, Burn Contact Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241225
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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