510(k) · Cleared
ClearedActicoat Primary Antimicrobial Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westaim Biomedical, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 7, 2000 as substantially equivalent to K983833 (Westaim Biomedical, Inc., 1998) and 1 other predicate after a 342-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Jun 7, 2000
- Review
- 342 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914579 (1992). 5 ancestors in all, the oldest K820198 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 2 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 1 generation backK983833 Acticoat Composite Wound Dressing, Acticoat Composite Wound…Westaim Biomedical, Inc. · 1998
- This deviceK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK011941 Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001
- Descendant · 2 generations on · 0 of its ownK070685 Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
- Descendant · cites it directly · 0 of its ownK050086 Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001 · cites it directly1descendant
- K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · 2 generations on0descendants
- K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −2 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −1 | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive | Westaim Biomedical, Inc. | 1998 | — |
| 0 (this device) | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| +1 | K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | The Kendall Company | 2001 | — |
| +2 | K070685 | Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| +1 | K050086 | Brennen Medical Silver Glucan Wound Dressing | Brennen Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive Our OCR of the scanned summary read K983883, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acticoat® Composite dressing”. | 1998 |
| Kept off the family tree | K820298 | FDA’s K820298 is Carcinoembryonic Antigen Control (4 Lev Our OCR of the scanned summary read K820298, FDA’s number for Carcinoembryonic Antigen Control (4 Lev (Ventrex Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “N'Terface dressing”. Kept off the family tree. Summary page 2…his configuration allows the user to choose an appropriate secondary dressing. This product is also similar to N'Terface dressing distributed by Winfield Laboratories. (K820298 and K973538). Both products are manufactured from HDPE and intended for use as a primary dressing to minimize damage to the wound… | 1982 |
| * | K973538 | N-TerfaceSummary page 2…ation allows the user to choose an appropriate secondary dressing. This product is also similar to N'Terface dressing distributed by Winfield Laboratories. (K820298 and K973538). Both products are manufactured from HDPE and intended for use as a primary dressing to minimize damage to the wound bed during… | 1997 |
What descends from it? (3)
2 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 8 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K011941 (The Kendall Company, 2001) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K983833.
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® silver coated contact layer dressing is an effective barrier to bacterial and fungal penetration.! The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds.
It has not been evaluated in third degree burns.
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/K992221 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992221: Acticoat Primary Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992221
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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