FDA product code KGN: Wound Dressing With Animal-Derived Material(S)
KGN is the FDA product code for wound dressing with animal-derived material(s). It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 192 510(k) submissions under KGN, 57 in the last five years, from 101 different applicants. The average 510(k) review took 155 days (median 122); 153 days on average over the last three years. FDA has posted 23 recalls for KGN devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Wound Dressing With Animal-Derived Material(S) |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KGN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 137 |
| 2018 | 6 | 136 |
| 2019 | 3 | 110 |
| 2020 | 5 | 249 |
| 2021 | 6 | 214 |
| 2022 | 12 | 239 |
| 2023 | 9 | 327 |
| 2024 | 13 | 129 |
| 2025 | 10 | 184 |
| 2026 | 13 | 147 |
Compare with all 510(k) review times · Search every KGN clearance
Top KGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acell, Inc. | 13 | 2024-07-11 |
| Collagen Matrix, Inc. | 8 | 2024-12-19 |
| Innocoll Pharmaceuticals | 6 | 2014-05-01 |
| Geistlich Pharma AG | 5 | 2026-03-19 |
| Kerecis Limited | 5 | 2025-07-16 |
96 more applicants have KGN clearances. See the full list in Caduvo.
Most recent KGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260652 | Covalon Technologies, Ltd. | ColActive Plus | 2026-09-09 | 194 |
| K260711 | Berkeley Advanced Biomaterials | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | 2026-08-27 | 175 |
| K260596 | Ventris Medical | Collagen Wound Powder | 2026-07-02 | 128 |
| K260669 | Aroa Biosurgery , Ltd. | Endoform Dermal Template | 2026-06-24 | 114 |
| K253521 | Ecm Therapeutics, Inc. | ECMT-100 WMD | 2026-06-18 | 217 |
Recalls for KGN devices
23 product recalls in 12 recall events; 15 initiated in the last five years and 15 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 6 |
| 2026 | 6 |
Frequently asked questions
What is FDA product code KGN?
KGN is the FDA product code for wound dressing with animal-derived material(s). It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is KGN?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGN?
Across 192 cleared submissions the average was 155 days from receipt to decision (median 122).
Which companies have the most KGN clearances?
Acell, Inc. (13); Collagen Matrix, Inc. (8); Innocoll Pharmaceuticals (6); Geistlich Pharma AG (5); Kerecis Limited (5).
Have KGN devices been recalled?
Yes: 23 product recalls across 12 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code KGN
- Run a recall and safety report across every KGN manufacturer
- Watch product code KGN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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