510(k) · Cleared
Recalled · Class II · 2022Silver Alginate 11 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 Feb 26, 2009 as substantially equivalent to K041316 (Advanced Medical Solutions, Ltd., 2004) and 2 other predicates after a 3-day review. Its family tree reaches back 5 generations to 1991. It has been recalled 3 times.
- Decided
- Feb 26, 2009
- Review
- 3 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 3
- Predicates
- 3
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 deviceK090453 Silver Alginate 11 Wound DressingAdvanced Medical Solutions Limited · 2009
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) | K090453 | Silver Alginate 11 Wound Dressing | Advanced Medical Solutions Limited | 2009 | — |
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? (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…devices intended for wound care. This product is already legally marketed as Silver Alginate II dressing (unmodified device) and was previously cleared under 510(k) # K041316, K063173 and K070581. All submissions were made by Advanced Medical Solutions Limited. Submitted by:- Advan… | 2004 |
| * | K063173 | Modification to Silver Alginate II Wound DressingSummary page 1…intended for wound care. This product is already legally marketed as Silver Alginate II dressing (unmodified device) and was previously cleared under 510(k) # K041316, K063173 and K070581. All submissions were made by Advanced Medical Solutions Limited. Submitted by:- Advanced Medic… | 2006 |
| * | K070581 | Silver Alginate II Wound DressingSummary page 1…wound care. This product is already legally marketed as Silver Alginate II dressing (unmodified device) and was previously cleared under 510(k) # K041316, K063173 and K070581. All submissions were made by Advanced Medical Solutions Limited. Submitted by:- Advanced Medical Solutions… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1806-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage… |
| May 25, 2022 | Class III | Z-1805-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage… |
| Jan 15, 2015 | Class II | Z-2719-2016 | Package design/selection | On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.3 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. 2009, 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 II Dressing is indicated for the management of moderate to heavily
exuding partial to full thickness wounds, such as:
Post-operative wounds
Trauma wounds (dermal lesions, trauma injuries or incisions)
Leg ulcers
Pressure ulcers
Diabetic ulcers
Graft and donor sites
Post-operative surgical wounds
1St and 2 nd degree bums
Partial and full thickness wounds
Silver Alginate II Dressing is indicated for external use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090453: Silver Alginate 11 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/K090453
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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