510(k) · Cleared
ClearedCovaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covalon Technologies, Ltd. · FRO Dressing, Wound, Drug
Cleared on Feb 3, 2006 as substantially equivalent to K043296 (Covalontechnologies, Inc., 2005) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 128 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002599 (2000). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002599 Modification to Acryderm Silver Antimicrobial Wound Dressing, Models…Acrymed, Inc. · 2000
- This deviceK052696 Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK063059 Sorbact Wound DressingAbigo Medical AB · 2007
- Descendant · 2 generations on · 1 of its ownK143151 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive…Bsn Medical GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK171225 Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017
- Descendant · 2 generations on · 0 of its ownK153674 Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016
- Descendant · 2 generations on · 0 of its ownK100591 SorbactAbigo Medical AB · 2011
Most influential descendants
Showing 5 of 5 · See all- K063059Sorbact Wound DressingAbigo Medical AB · 2007 · cites it directly4descendants
- K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…Bsn Medical GmbH · 2015 · 2 generations on1descendant
- K171225Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017 · 2 generations on0descendants
- K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016 · 2 generations on0descendants
- K100591SorbactAbigo Medical AB · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002599 | Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041… | Acrymed, Inc. | 2000 | — |
| 0 (this device) | K052696 | Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing | Covalon Technologies, Ltd. | 2006 | — |
| +1 | K063059 | Sorbact Wound Dressing | Abigo Medical AB | 2007 | — |
| +2 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact… | Bsn Medical GmbH | 2015 | — |
| +2 | K171225 | Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB | 2017 | — |
| +2 | K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Abigo Medical AB | 2016 | — |
| +2 | K100591 | Sorbact | Abigo Medical AB | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K043296 | Colactive AG Collagen with Silver Antimicrobial DressingSummary page 1…PRODUCT CODE FRO) SUBSTANTIAL ColActiveAgTM Collagen with Silver Antimicrobial EQUIVALENCE: Wound Dressing (k043296) SilvaSorb® Silver Antimicrobial Dressing (k002599) 510 (k) Notification… | 2005 |
| * | K002599 | Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043…Summary page 1…olActiveAgTM Collagen with Silver Antimicrobial EQUIVALENCE: Wound Dressing (k043296) SilvaSorb® Silver Antimicrobial Dressing (k002599) 510 (k) Notification / CovaClear AgT M Collagen with Silver, Antimicrobial Gel Sheet Dressing C… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063059 | Sorbact Wound Dressing | 2007 | 4 |
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?
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?
CovaClearAg Collagen with Silver, Antimicrobial Gel Sheet Dressing is indicated for the management of full and partial thickness wounds including:
pressure ulcers
diabetic ulcers
ulcers caused by mixed vascular etiologies
venous ulcers
donor and graft sites
abrasions and lacerations
traumatic wounds healing by secondary intention
de hisced surgical wounds
first and second degree burns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052696: Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052696
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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