510(k) · Cleared
ClearedModification to Silver Alginate II Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Solutions Limited · FRO Dressing, Wound, Drug
Cleared on Nov 3, 2006 as substantially equivalent to K041316 (Advanced Medical Solutions, Ltd., 2004) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 3, 2006
- Review
- 15 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914575 (1991). 7 ancestors in all. 3 later devices descend from it, 3 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 deviceK063173 Modification to Silver Alginate II Wound DressingAdvanced Medical Solutions Limited · 2006
- Descendant · cites it directly · 0 of its ownK090453 Silver Alginate 11 Wound DressingAdvanced Medical Solutions Limited · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK080503 Silver Alginate IV Antimicrobial Wound DressingAdvanced Medical Solutions Limited · 2008
- Descendant · cites it directly · 0 of its ownK081363 Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent…Advanced Medical Solutions Limited · 2008
Most influential descendants
Showing 3 of 3 · See all- K090453Silver Alginate 11 Wound DressingAdvanced Medical Solutions Limited · 2009 · cites it directly0descendants
- K080503Silver Alginate IV Antimicrobial Wound DressingAdvanced Medical Solutions Limited · 2008 · cites it directly0descendants
- K081363Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial…Advanced Medical Solutions Limited · 2008 · 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) | K063173 | Modification to Silver Alginate II Wound Dressing | Advanced Medical Solutions Limited | 2006 | — |
| +1 | K090453 | Silver Alginate 11 Wound Dressing | Advanced Medical Solutions Limited | 2009 | 3 |
| +1 | K080503 | Silver Alginate IV Antimicrobial Wound Dressing | Advanced Medical Solutions Limited | 2008 | — |
| +1 | K081363 | Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent… | Advanced Medical Solutions Limited | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K041316 | Antimicrobial Alginate DressingSummary page 1…Maxsorb Extra Ag Seasorb Ag hnvacare Silver Alginate Dressing Predicate devices:- K041316 Silver Alginate II Dressing manufactured by Advanced Medical Solutions… | 2004 |
| * | K013814 | Absorbent Antimicrobial Wound DressingSummary page 1…Predicate devices:- K041316 Silver Alginate II Dressing manufactured by Advanced Medical Solutions K013814 Aquacel Ag with hydrofibre manufactured by ConVatec, A division of E.R Squibb and Sons LLC. === Pa… | 2002 |
| * | — | Anticoat® Calcium Alginate Dressing Named without a submission number |
What descends from it? (3)
3 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 15 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K090453 (Advanced Medical Solutions Limited, 2009) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K041316.
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?
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including:
* Post-operative wounds
* Trauma wounds
* Leg Ulcers
* Pressure Ulcers
* Diabetic Ulcers
* Graft and donor sites
Silver Alginate II Dressing is indicated for external use only.
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/K063173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063173: Modification to Silver Alginate II Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063173
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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