510(k) · Cleared
ClearedActicoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westaim Biomedical, Inc. · KMF Bandage, Liquid
Cleared on Dec 10, 1998 as substantially equivalent to K955453 (Westaim Technologies, Inc., 1996) after a 41-day review. Its family tree reaches back 2 generations to 1992. 8 later devices descend from it.
- Decided
- Dec 10, 1998
- Review
- 41 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914579 (1992). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 1 generation backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- This deviceK983833 Acticoat Composite Wound Dressing, Acticoat Composite Wound…Westaim Biomedical, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK032463 Curad Silver BandageBeiersdorf AG · 2004
- Descendant · 2 generations on · 1 of its ownK011941 Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001
- Descendant · 2 generations on · 0 of its ownK100580 Exsalt Wound DressingExciton Technologies, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK082910 CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K992221Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000 · cites it directly3descendants
- K032463Curad Silver BandageBeiersdorf AG · 2004 · cites it directly2descendants
- K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001 · 2 generations on1descendant
- K100580Exsalt Wound DressingExciton Technologies, Inc. · 2010 · 2 generations on0descendants
- K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −1 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| 0 (this device) | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive | Westaim Biomedical, Inc. | 1998 | — |
| +1 | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| +1 | K032463 | Curad Silver Bandage | Beiersdorf AG | 2004 | — |
| +2 | K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | The Kendall Company | 2001 | — |
| +2 | K100580 | Exsalt Wound Dressing | Exciton Technologies, Inc. | 2010 | — |
| +2 | K082910 | CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver Bandages | Aso, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 KMF? 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 KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K955453 | Acticoat Silver Coated DressingSummary page 2…arketed wound dressings. Specifically, Acticoat® Composite Wound Dressing is substantially equivalent The Westaim Corporation’s Acticoat® Antimicrobial Barrier Dressing (K955453) and Bioderm’s Composite Wound Dressing. The wound contact layer is also substantially equivalent to the Conformant 2® Wound Dre… | 1996 |
| * | — | Bioderm’s Composite Wound Dressing Named without a submission number | |
| * | — | Conformant 2® Wound Dressing Named without a submission number |
What descends from it? (8)
4 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 6 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K992221 (Westaim Biomedical, Inc., 2000) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K955453.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, 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 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted 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/K983833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983833: Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983833
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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