510(k) · Cleared
ClearedCMB Antimicrobial Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silverleaf Medical Products, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 15, 2006 as substantially equivalent to K955453 (Westaim Technologies, Inc., 1996) and 2 other predicates after a 136-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jun 15, 2006
- Review
- 136 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914579 (1992). 6 ancestors in all. 4 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 deviceK060237 CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK081977 Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK130350 ProcelleraVomaris Innovations, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK160783 ProcelleraVomaris Innovations, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK180533 Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K081977Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008 · cites it directly3descendants
- K130350ProcelleraVomaris Innovations, Inc. · 2013 · cites it directly2descendants
- K160783ProcelleraVomaris Innovations, Inc. · 2016 · cites it directly1descendant
- K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018 · cites it directly0descendants
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) | K060237 | CMB Antimicrobial Dressing | Silverleaf Medical Products, Inc. | 2006 | — |
| +1 | K081977 | Prosit Wound Treatment Device | Silverleaf Medical Products, Inc. | 2008 | — |
| +1 | K130350 | Procellera | Vomaris Innovations, Inc. | 2013 | — |
| +1 | K160783 | Procellera | Vomaris Innovations, Inc. | 2016 | — |
| +1 | K180533 | Procellera Composite Antibacterial Wound Dressing | Vomaris Wound Care, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K955453 | Acticoat Silver Coated DressingSummary page 1…CMB Antimicrobial Dressing Predicate Device Names: Acticoat Antimicrobial Dressing (K955453) Hydrocolloid with Zinc Wound Dre… | 1996 |
| * | K973855 | IT Hydrocolloid with ZincSummary page 1…(K955453) Hydrocolloid with Zinc Wound Dressing (K973855) Absorbent Antimicrobial Wound Dr… | 1997 |
| * | K033814 | Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007Summary page 1…Dressing (K973855) Absorbent Antimicrobial Wound Dressing (K033814) Device The CMB Antimicrobial dressing is a single layer dressing Description consisting of a woven adsorbent p… | 2004 |
What descends from it? (4)
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 14 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K081977 (Silverleaf Medical Products, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K955453.
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 CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, bums and donor and recipient graft sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060237: CMB Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060237
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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