510(k) · Cleared
ClearedSilverlon Adhesive Strip
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 17, 2003 as substantially equivalent to K910657 (Deroyal Industries, Inc., 1991) and 1 other predicate after an 81-day review. Its family tree reaches back 3 generations to 1992. 21 later devices descend from it.
- Decided
- Jan 17, 2003
- Review
- 81 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914579 (1992). 6 ancestors in all, the oldest K890354 (1989). 21 later devices descend from it, 6 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 deviceK023609 Silverlon Adhesive StripArgentum International, LLC · 2003
- Descendant · cites it directly · 9 of its ownK033587 SilversealNoble Fiber Technologies · 2004
- Descendant · cites it directly · 6 of its ownK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · 2 generations on · 5 of its ownK050649 Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK083133 Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing…Andover Healthcare, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K033587SilversealNoble Fiber Technologies · 2004 · cites it directly9descendants
- K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009 · cites it directly6descendants
- K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005 · 2 generations on5descendants
- K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc. · 2009 · 3 generations on3descendants
- K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009 · 2 generations on2descendants
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) | K023609 | Silverlon Adhesive Strip | Argentum International, LLC | 2003 | — |
| +1 | K033587 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +1 | K082333 | Asap Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +2 | K050649 | Silverseal Contacting Wound Dressing with X-Static | Noble Fiber Technologies, Inc. | 2005 | — |
| +3 | K083133 | Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex… | Andover Healthcare, Inc. | 2009 | — |
| +2 | K092826 | Asap Antimicrobial Silver Wound Dressing Gel | American Biotech Labs | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K910657 | Qualtex Island DressingSummary page 1…erlonB Adhesive Strip is substantially equivalent with respect to function, intended use, and composition to: 1. Qualtex Island Dressing (K9 10657); 2. SilverlonB Contact Wound Dressing (K98 1299). 10.1.4 Device Description Explanation of how the de… | 1991 |
| * | K981299 | Silverlon Contact Wound DressingSummary page 1…function, intended use, and composition to: 1. Qualtex Island Dressing (K9 10657); 2. SilverlonB Contact Wound Dressing (K98 1299). 10.1.4 Device Description Explanation of how the device functions: Silver nylon strips are… | 1998 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 ancestors has a recall.
- Of its descendants, K033587 (Noble Fiber Technologies, 2004) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K910657.
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?
Indicated for vascular access, central, arterial and venous IV sites, IM injection sites, abrasions, lacerations, partial thickness burns, wound drain sites and surgical incisions.
First aid to help in minor cuts, scrapes, abrasions and burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023609: Silverlon Adhesive Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023609
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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