510(k) · Cleared
ClearedSilverlon CA (Calcium Alginate)
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 Oct 6, 2006 as substantially equivalent to K011618 (Adri, 2002) and 2 other predicates after a 287-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Oct 6, 2006
- Review
- 287 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K914575 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 3 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 2 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 1 generation backK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004
- This deviceK053590 Silverlon CA (Calcium Alginate)Argentum Medical, LLC · 2006
- Descendant · cites it directly · 0 of its ownK192478 LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −3 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −2 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −1 | K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| 0 (this device) | K053590 | Silverlon CA (Calcium Alginate) | Argentum Medical, LLC | 2006 | — |
| +1 | K192478 | LT Antibacterial Alginate with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K011618 | Calgitrol AG Silver Alginate Wound Dressing | 2002 |
| * | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate DressingSummary page 1…Westaim Medical, LLC and for approved Silver Alginate dressings ADRI -KO1 1618; - K002896 and Advanced Medical Solutions - K041316 6.1.4 Device Description… | 2001 |
| * | K041316 | Antimicrobial Alginate DressingSummary page 1…Westaim Medical, LLC and for approved Silver Alginate dressings ADRI -KO1 1618; - K002896 and Advanced Medical Solutions - K041316 6.1.4 Device Description non-wov… | 2004 |
| * | — | prior Silverlon products distributed by Argentum Medical, LLC Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192478 | LT Antibacterial Alginate with Silver Dressing | 2020 | 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 15 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K192478 (Zhejiang Longterm Medical Technology Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011618.
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?
SilverlonTM CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. SilverlonTM CA Advanced Antimicrobial Dressing is indicated for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053590: Silverlon CA (Calcium Alginate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053590
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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