510(k) · Cleared
ClearedSilver Alginate IV Antimicrobial 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 12, 2008 as substantially equivalent to K041316 (Advanced Medical Solutions, Ltd., 2004) and 3 other predicates after a 261-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Nov 12, 2008
- Review
- 261 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K914575 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 4 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 3 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 2 generations backK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004
- 1 generation backK063173 Modification to Silver Alginate II Wound DressingAdvanced Medical Solutions Limited · 2006
- This deviceK080503 Silver Alginate IV Antimicrobial Wound DressingAdvanced Medical Solutions Limited · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −4 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −3 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −2 | K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| −1 | K063173 | Modification to Silver Alginate II Wound Dressing | Advanced Medical Solutions Limited | 2006 | — |
| 0 (this device) | K080503 | Silver Alginate IV Antimicrobial Wound Dressing | 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 |
| 2007 | 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 |
|---|---|---|---|
| * | K041316 | Antimicrobial Alginate DressingSummary page 1…Unclassified Product Code:- FRO Legally marketed device(s) for substantial equivalence comparison:- Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions. Aquacel Ag with hydrofibre (Absorbent Antimicrobial Wound Dressing),… | 2004 |
| * | K063173 | Modification to Silver Alginate II Wound DressingSummary page 1…Unclassified Product Code:- FRO Legally marketed device(s) for substantial equivalence comparison:- Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions. Aquacel Ag with hydrofibre (Absorbent Antimicrobial Wound Dressing), 510(k)… | 2006 |
| * | K070581 | Silver Alginate II Wound DressingSummary page 1…lassified Product Code:- FRO Legally marketed device(s) for substantial equivalence comparison:- Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions. Aquacel Ag with hydrofibre (Absorbent Antimicrobial Wound Dressing), 510(k) # KO 138… | 2007 |
| * | K013814 | Absorbent Antimicrobial Wound DressingSummary page 2…Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions and Aquacel Ag with hydrofibre (Absorbent Antimicrobial Wound Dressing), 510(k) # K013814, manufactured by ConvaTec, A division of E.R Squibb and Sons LLC. The biocompatibility and performance testing for the Silver Alg… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 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. 2008, this device’s year, is highlighted.
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 IV Antimicrobial Wound Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:
· Post-operative wounds
· Trauma wounds (denral lesions, trauma injuries or incisions)
* Leg Ulcers
* Pressures Ulcers
• Diabetic Ulcers
* Graft and donor sites
* Post-operative surgical wounds
• 1st and 2 nd degree bums
* Partial and Full Thickness wounds
Silver Alginate IV Antimicrobial Wound Dressing is indicated for external use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080503: Silver Alginate IV Antimicrobial Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080503
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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