510(k) · Cleared
ClearedSilverlon Contact Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argentum International, LLC · FRO Dressing, Wound, Drug
Cleared on Jan 24, 2003 as substantially equivalent to K981299 (Argentum International, LLC, 1998) after an 88-day review. Its family tree reaches back 3 generations to 1992. 102 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 88 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914579 (1992). 5 ancestors in all, the oldest K890354 (1989). 102 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 2 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 1 generation backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- This deviceK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- Descendant · cites it directly · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 2 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 3 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 4 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · cites it directly73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 2 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 3 generations on37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 3 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −2 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −1 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| 0 (this device) | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| +1 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +2 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +3 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +4 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K981299 | Silverlon Contact Wound Dressing | 1998 |
What descends from it? (102)
See all 10210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063069 | Silvaklenz Skin and Wound Clenser Solution | 2007 | 73 |
| K063063 | Silvacide Skin & Wound Moisturizing Solution | 2007 | 14 |
| K033587 | Silverseal | 2004 | 9 |
| K120181 | Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM… | 2013 | 6 |
| K073213 | Therabond Antimicrobial Barrier Systems | 2008 | 5 |
| K050649 | Silverseal Contacting Wound Dressing with X-Static | 2005 | 5 |
| K150256 | Silverlon Burn Contact Dressings | 2015 | 4 |
| K051445 | Milliken Silver Wound Dressings | 2005 | 3 |
| K050726 | Silverseal Silveraid with X-Static | 2005 | 2 |
| K050842 | Agcel Wound Dressing,Agcel Burn Dressing | 2006 | 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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063069 (Medical Molecular Therapuetics, LLC, 2007) has gone furthest, with 73 descendants of its own.
- 12 other devices also cite its predicate K981299.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For over-the-counter use, SilverlonB Wound Contact Dressing may be used for:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Under the supervision of a health care professional, SilverlonB Wound Contact Dressing may be used for the management of
SilverlonB Wound Contact Dressings provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023612: Silverlon Contact 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/K023612
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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