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 Sep 25, 1998 as substantially equivalent to K970566 (Maersk Medical, Ltd., 1997) and 2 other predicates after a 169-day review. Its family tree reaches back 2 generations to 1992. 149 later devices descend from it.
- Decided
- Sep 25, 1998
- Review
- 169 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914579 (1992). 4 ancestors in all, the oldest K890354 (1989). 149 later devices descend from it, 13 citing it directly.
- Root · 2 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 1 generation backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- This deviceK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- Descendant · cites it directly · 102 of its ownK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 3 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 4 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 149 · See all- K023612Silverlon Contact Wound DressingArgentum International, LLC · 2003 · cites it directly102descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 3 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 4 generations on37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −1 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| 0 (this device) | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| +1 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| +2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +4 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
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 |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 9 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 4 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K970566 | Arglaes Film DressingSummary page 1…Silverlon™ Contact Wound Dressings are substantially equivalent in function and intended use to the following clcared contact wound dressings: Arglacs Filin Dressing (K970566), Acticoat Silver Coated Dressing (K955453), and Tegapore™ Wound Contact Material (K890354). P .83 99-23-98 0@3… | 1997 |
| * | K955453 | Acticoat Silver Coated DressingSummary page 1…bstantially equivalent in function and intended use to the following clcared contact wound dressings: Arglacs Filin Dressing (K970566), Acticoat Silver Coated Dressing (K955453), and Tegapore™ Wound Contact Material (K890354). P .83 99-23-98 0@3:44P P.04 VFHRnn‘= THE WEINBERG GROUP FAX… | 1996 |
| * | K890354 | Tegapore Wound Contact Material, Product #563XSummary page 1…use to the following clcared contact wound dressings: Arglacs Filin Dressing (K970566), Acticoat Silver Coated Dressing (K955453), and Tegapore™ Wound Contact Material (K890354). P .83 99-23-98 0@3:44P P.04 VFHRnn‘= THE WEINBERG GROUP FAX NO.: 2028334157 Argentum International LLC 510(k… | 1989 |
What descends from it? (149)
See all 14913 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023612 | Silverlon Contact Wound Dressing | 2003 | 102 |
| K984210 | Silverlon Wound Packing Strips | 1999 | 25 |
| K083113 | Acticoat Flex 7 Dressing | 2009 | 22 |
| K023609 | Silverlon Adhesive Strip | 2003 | 21 |
| K984208 | Silverlon Island Dressing, Silverlon Island Pad | 1999 | 14 |
| K033587 | Silverseal | 2004 | 9 |
| K073213 | Therabond Antimicrobial Barrier Systems | 2008 | 5 |
| K153756 | Microlyte Ag | 2016 | 1 |
| K040518 | Select Fabricators, Inc., Agmed Tex Wound Dressing | 2004 | 1 |
| K141033 | Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG… | 2014 | 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 6 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K023612 (Argentum International, LLC, 2003) has gone furthest, with 102 descendants of its own.
- 4 other devices also cite its predicate K970566.
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?
Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981299: Silverlon Contact Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981299
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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