510(k) · Cleared
Clearedscaffolene CL100 Bioresorbable Collagen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freudenberg Technology Innovation SE & Co. KG · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 28, 2020 as substantially equivalent to K123756 (Covalon Technologies, Ltd., 2013) after a 183-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Feb 28, 2020
- Review
- 183 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K061554 (2007). 5 ancestors in all, the oldest K050177 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK061554 Mepilex AG Absorbent Silicone-Coated DressingMolnlycke Health Care · 2007
- 3 generations backK100029 Mepilex Border AG DressingMolnlycke Health Care · 2010
- 2 generations backK123892 Mepilex Transfer AGMolnlycke Health Care · 2013
- 1 generation backK123756 CovagenCovalon Technologies, Ltd. · 2013
- This deviceK192346 scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K061554 | Mepilex AG Absorbent Silicone-Coated Dressing | Molnlycke Health Care | 2007 | — |
| −3 | K100029 | Mepilex Border AG Dressing | Molnlycke Health Care | 2010 | — |
| −2 | K123892 | Mepilex Transfer AG | Molnlycke Health Care | 2013 | — |
| −1 | K123756 | Covagen | Covalon Technologies, Ltd. | 2013 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K123756 | CovagenSummary page 4…Unclassified, Preamendment Product Code: KGN Predicate Device: Covalon Technologies ColActive® Transfer (K123756) Reason for Submission: New Device Device Description scaffolene® CL100 Bioresorbable Collagen Matrix is a collagen… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
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. 2020, 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?
scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients 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/K192346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192346: scaffolene CL100 Bioresorbable Collagen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192346
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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