510(k) · Cleared
ClearedSilverlon Burn Contact Dressings
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 Apr 30, 2015 as substantially equivalent to K023612 (Argentum International, LLC, 2003) and 2 other predicates after an 86-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 30, 2015
- Review
- 86 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K914579 (1992). 18 ancestors in all, the oldest K890354 (1989). 4 later devices descend from it, 1 citing it directly.
- 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 backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 1 generation backK073213 Therabond Antimicrobial Barrier SystemsChoice Therapeutics · 2008
- This deviceK150256 Silverlon Burn Contact DressingsArgentum Medical · 2015
- Descendant · cites it directly · 3 of its ownK190343 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK221218 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK241225 Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK212521 Field Shield Wound DressingKericure, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019 · cites it directly3descendants
- K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022 · 2 generations on1descendant
- K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024 · 3 generations on0descendants
- K212521Field Shield Wound DressingKericure, Inc. · 2024 · 2 generations on0descendants
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 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −1 | K073213 | Therabond Antimicrobial Barrier Systems | Choice Therapeutics | 2008 | — |
| 0 (this device) | K150256 | Silverlon Burn Contact Dressings | Argentum Medical | 2015 | — |
| +1 | K190343 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, LLC | 2019 | — |
| +2 | K221218 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, Inc. | 2022 | — |
| +3 | K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | 2024 | — |
| +2 | K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024 | — |
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 | 2 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K023612 | Silverlon Contact Wound DressingSummary page 4…rug 5.6. Classification name Unclassified: Pre-Amendment 21 CFR Number: None Product code: FRO 5.7. Substantially Equivalent Devices (Predicates): K023612; Silverlon® Antimicrobial Barrier Wound Contact Dressing, Antimicrobial Barrier Burn Wrap Dressing, Antimicrobial Barrier Burn Co… | 2003 |
| * | K073213 | Therabond Antimicrobial Barrier SystemsSummary page 4…lverlon® Antimicrobial Barrier Wound Contact Dressing, Antimicrobial Barrier Burn Wrap Dressing, Antimicrobial Barrier Burn Contact Dressing, SilverlonB Acute Burn Glove K073213; TheraBond Antimicrobial Barrier Systems K122817; Silverlon® Island Wound Dressing 2015-01-30… | 2008 |
| * | K122817 | Silverlon Island Wound DressingSummary page 4…sing, Antimicrobial Barrier Burn Wrap Dressing, Antimicrobial Barrier Burn Contact Dressing, SilverlonB Acute Burn Glove K073213; TheraBond Antimicrobial Barrier Systems K122817; Silverlon® Island Wound Dressing 2015-01-30 P… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190343 | Silverlon Wound Contact, Burn Contact Dressings | 2019 | 3 |
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 23 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K190343 (Argentum Medical, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K023612.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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® Wound Contact, Burn Contact Dressings are comprised of a single layer of knitted nylon fiber substrate coated with metallic silver. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Prescription Indications: 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…
Read the full statement (203 words)
Silverlon® Wound Contact, Burn Contact Dressings are comprised of a single layer of knitted nylon fiber substrate coated with metallic silver.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Prescription Indications:
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), 1st and 2nd degree 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® 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® 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, Burn Contact Dressings is 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/K150256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150256: Silverlon Burn Contact Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150256
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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