510(k) · Cleared
ClearedColactive Collagen Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covalontechnologies, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Apr 27, 2005 after a 91-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 27, 2005
- Review
- 91 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK050177 Colactive Collagen Wound DressingCovalontechnologies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK123756 CovagenCovalon Technologies, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK260652 ColActive PlusCovalon Technologies, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK192346 scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG · 2020
- Descendant · cites it directly · 0 of its ownK091338 Collasorb Collagen Wound DressingHartmann-Conco, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K123756CovagenCovalon Technologies, Ltd. · 2013 · cites it directly1descendant
- K260652ColActive PlusCovalon Technologies, Ltd. · 2026 · cites it directly0descendants
- K192346scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG · 2020 · 2 generations on0descendants
- K091338Collasorb Collagen Wound DressingHartmann-Conco, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050177 | Colactive Collagen Wound Dressing | Covalontechnologies, Inc. | 2005 | — |
| +1 | K123756 | Covagen | Covalon Technologies, Ltd. | 2013 | — |
| +1 | K260652 | ColActive Plus | Covalon Technologies, Ltd. | 2026 | — |
| +2 | K192346 | scaffolene CL100 Bioresorbable Collagen Matrix | Freudenberg Technology Innovation SE & Co. KG | 2020 | — |
| +1 | K091338 | Collasorb Collagen Wound Dressing | Hartmann-Conco, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | FIBRACOL PLUS Collagen Wound Dressing with Alginate Named without a submission number | |
| * | — | SkinTemp Kollagen Wound Management Material Named without a submission number |
What descends from it? (4)
3 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?
- Of its descendants, K123756 (Covalon Technologies, Ltd., 2013) has gone furthest, with 1 descendant of its own.
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.
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?
ColActive Tm Collagen Wound 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
Second degree bums
Donor and graft sites
Abrasions
Dehisced surgical wounds
Traumatic wounds healing by secondary intention
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/K050177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050177: Colactive Collagen Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050177
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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