510(k) · Cleared
ClearedActicoat Silver Coated Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westaim Technologies, Inc. · KMF Bandage, Liquid
Cleared on May 31, 1996 as substantially equivalent to K914579 (Vitaphore Corp., 1992) after a 184-day review. Its family tree reaches back 1 generation to 1992. 161 later devices descend from it.
- Decided
- May 31, 1996
- Review
- 184 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914579 (1992). 161 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- This deviceK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- Descendant · cites it directly · 149 of its ownK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- Descendant · 2 generations on · 102 of its ownK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- Descendant · 3 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 4 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 5 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K981299Silverlon Contact Wound DressingArgentum International, LLC · 1998 · cites it directly149descendants
- K023612Silverlon Contact Wound DressingArgentum International, LLC · 2003 · 2 generations on102descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 3 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 4 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 5 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| 0 (this device) | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| +1 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| +2 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| +3 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +4 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +5 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 12 | 0 |
| 2015 | 9 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 4 | 0 |
| 2026 | 12 | 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? (1)
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 |
|---|---|---|---|
| * | K914579 | Silver Foam Wound DressingSummary page 2…er legally marketed burn and wound dressings. Specifically, Acticoat™ silver coated dressing is substantially equivalent to Vitaphore Corporation’s Silver Foam Dressing (K914579). Intended Use Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a m… | 1992 |
What descends from it? (161)
See all 1617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981299 | Silverlon Contact Wound Dressing | 1998 | 149 |
| K033587 | Silverseal | 2004 | 9 |
| K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive | 1998 | 8 |
| K060237 | CMB Antimicrobial Dressing | 2006 | 4 |
| K053256 | 3M Tegaderm Silver (AG) Mesh | 2005 | 1 |
| K063805 | Silcryst Silver Antimicrobial Wound Cream, Model a-00901 | 2007 | 0 |
| K050086 | Brennen Medical Silver Glucan Wound Dressing | 2006 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K981299 (Argentum International, LLC, 1998) has gone furthest, with 149 descendants of its own.
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?
Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full 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/K955453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955453: Acticoat Silver Coated Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955453
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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