510(k) · Cleared
ClearedCovagen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covalon Technologies, Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 16, 2013 as substantially equivalent to K050177 (Covalontechnologies, Inc., 2005) and 1 other predicate after a 252-day review. Its family tree reaches back 3 generations to 2007. 1 later device descends from it.
- Decided
- Aug 16, 2013
- Review
- 252 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K061554 (2007). 4 ancestors in all, the oldest K050177 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK061554 Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care · 2007
- 2 generations backK100029 Mepilex Border AG DressingMolnlycke Health Care · 2010
- 1 generation backK123892 Mepilex Transfer AGMolnlycke Health Care · 2013
- This deviceK123756 CovagenCovalon Technologies, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK192346 scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG · 2020
Most influential descendants
Showing 1 of 1 · See all- K192346scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061554 | Mepilex AG Absorbent Silicone-Coated Dressing | Molnlycke Health Care | 2007 | — |
| −2 | K100029 | Mepilex Border AG Dressing | Molnlycke Health Care | 2010 | — |
| −1 | K123892 | Mepilex Transfer AG | Molnlycke Health Care | 2013 | — |
| 0 (this device) | K123756 | Covagen | Covalon Technologies, Ltd. | 2013 | — |
| +1 | K192346 | scaffolene CL100 Bioresorbable Collagen Matrix | Freudenberg Technology Innovation SE & Co. KG | 2020 | — |
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 |
|---|---|---|
| 2020 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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 |
|---|---|---|---|
| * | K050177 | Colactive Collagen Wound DressingSummary page 1…ices Manufacturer Device 510(k)~ number Covalon Technologies ColActive" Collagen Wound Dressing K050177 Molnlycke Health Care Mepilex ® Transfer Ag K123892 US, LLC 4. Indications for use ColActive®… | 2005 |
| * | K123892 | Mepilex Transfer AG Cleared while this submission was under review Summary page 1…(k)~ number Covalon Technologies ColActive" Collagen Wound Dressing K050177 Molnlycke Health Care Mepilex ® Transfer Ag K123892 US, LLC 4. Indications for use ColActive® Transfer is indicated for management of full and partial thickness wounds including… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192346 | scaffolene CL100 Bioresorbable Collagen Matrix | 2020 | 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192346 (Freudenberg Technology Innovation SE & Co. KG, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K050177.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
CalActive® Transfer, is indicated for management of full and partial thickness wounds including pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123756: Covagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123756
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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