510(k) · Cleared
ClearedActicoat Foam Dressing, Algisite M Calcium Alginate Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Westaim Corp. · FRO Dressing, Wound, Drug
Cleared on Feb 21, 2001 as substantially equivalent to K000051 (Westaim Biomedical, Inc., 2000) and 1 other predicate after a 156-day review. Its family tree reaches back 2 generations to 1991. 83 later devices descend from it.
- Decided
- Feb 21, 2001
- Review
- 156 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914575 (1991). 4 ancestors in all. 83 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 1 generation backK983210 Algisite MSmith & Nephew, Inc. · 1998
- This deviceK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- Descendant · cites it directly · 53 of its ownK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- Descendant · 2 generations on · 25 of its ownK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- Descendant · 2 generations on · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- Descendant · cites it directly · 16 of its ownK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004
- Descendant · cites it directly · 12 of its ownK022483 Actisorb Silver 220 Antimicrobial Binding DressingJohnson & Johnson Medical, Ltd. · 2003
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K024298Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003 · cites it directly53descendants
- K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004 · 2 generations on25descendants
- K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · 2 generations on17descendants
- K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004 · cites it directly16descendants
- K022483Actisorb Silver 220 Antimicrobial Binding DressingJohnson & Johnson Medical, Ltd. · 2003 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −1 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| 0 (this device) | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| +1 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| +2 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| +2 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| +1 | K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| +1 | K022483 | Actisorb Silver 220 Antimicrobial Binding Dressing | Johnson & Johnson Medical, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K000051 | Acticoat Foam DressingSummary page 1…al classification for wound/burn dressings has not been implemented. Trade Name: Acticoat® Calcium Alginate Dressing Common Name: Alginate Dressing Predicate Devices: K000051 Acticoat® Foam Dressing K983210 Algisite M Calcium Alginate Dressing Indication for Use: The Acticoat® Calcium Alginate Dressin… | 2000 |
| * | K983210 | Algisite MSummary page 1…dressings has not been implemented. Trade Name: Acticoat® Calcium Alginate Dressing Common Name: Alginate Dressing Predicate Devices: K000051 Acticoat® Foam Dressing K983210 Algisite M Calcium Alginate Dressing Indication for Use: The Acticoat® Calcium Alginate Dressing is an effective barrier to bac… | 1998 |
What descends from it? (83)
See all 835 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 10 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K024298 (Advanced Medical Solutions, Ltd., 2003) has gone furthest, with 53 descendants of its own.
- 2 other devices also cite its predicate K000051.
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?
The Acticoat® Caleium Alginate Dressing is an effective barrier to bacterial penetration., The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.
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/K002896 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002896: Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002896
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026