510(k) · Cleared
Recalled · Class II · 2026Medline Collagen Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 19, 2006 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 19, 2006
- Review
- 117 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK060456 Medline Collagen Wound DressingMedline Industries, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK231152 Collagen Wound DressingWinner Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252001 Collagen Wound DressingWinner Medical Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK213598 LUOFUCON Collagen Wound DressingHuizhou Foryou Medical Devices Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K231152Collagen Wound DressingWinner Medical Co., Ltd. · 2023 · cites it directly1descendant
- K252001Collagen Wound DressingWinner Medical Co., Ltd. · 2025 · 2 generations on0descendants
- K213598LUOFUCON Collagen Wound DressingHuizhou Foryou Medical Devices Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060456 | Medline Collagen Wound Dressing | Medline Industries, Inc. | 2006 | — |
| +1 | K231152 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2023 | — |
| +2 | K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2025 | — |
| +1 | K213598 | LUOFUCON Collagen Wound Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2026 | Class II | Z-1650-2026 | Under Investigation by firm | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K231152 (Winner Medical Co., Ltd., 2023) 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?
Medline's Collagen 'Wound Dressing is indicated for the management of wounds including:
* Full thickness and partial thickness wounds
* Pressure ulcers
* Venous ulcers
* Ulcers caused by mixed vascular etiologies
* Diabetic ulcers
* Partial and full thickness bums
* Donor sites and other bleeding surface wounds
* Abrasions
* Traumatic wounds healing by secondary intention
* Dehisced surgical incisions
These dressings may be cut to size and may be layered for the management of deep wounds.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060456 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060456: Medline 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/K060456
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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