Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KGN — Predicate Candidate Screening
190 FDA 510(k) clearances under this product code; the 50 most recent screened below.
121 daysmedian FDA review time
306 days90th percentile
190clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260596 | Collagen Wound Powder | Ventris Medical | 2026-07-02 | 128 | 0 |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | 2026-06-24 | 114 | 0 |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | 2026-06-18 | 217 | 0 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 | 252 | 0 |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 | 174 | 0 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 | 169 | 0 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026-05-14 | 30 | 0 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 | 30 | 0 |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 2026-02-19 | 27 | 0 |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 2026-02-10 | 138 | 0 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 | 268 | 0 |
| K253339 | Theracor | Stimlabs, LLC | 2025-12-22 | 83 | 0 |
| K252673 | LacertaMatrix | Lacerta Life Science | 2025-12-22 | 119 | 0 |
| K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | 2025-12-19 | 273 | 0 |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | 2025-10-16 | 455 | 0 |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2025-10-10 | 105 | 0 |
| K250397 | Helios Dermal Scaffold | Helios Biomedical, Inc. | 2025-08-15 | 184 | 0 |
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025-07-16 | 30 | 0 |
| K250329 | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | 2025-06-25 | 140 | 0 |
| K242985 | CollOvine™ Wound Dressing | Ovigenex, LLC | 2025-06-20 | 267 | 0 |
| K241904 | DermiSphere Dermal Template | Fesariustherapeutics, Inc. | 2025-01-06 | 189 | 0 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | 2024-12-19 | 83 | 0 |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Limited | 2024-12-17 | 147 | 0 |
| K242828 | Corplex P/ Theracor P/ Allacor P | Stimlabs, LLC | 2024-10-18 | 29 | 0 |
| K233378 | ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. | 2024-10-18 | 382 | 0 |
| K241080 | Kerecis Parvus (50207) | Kerecis Limited | 2024-08-21 | 124 | 0 |
| K241866 | InnovaMatrix®FD | Convatec Triad Life Sciences, LLC | 2024-07-26 | 29 | 0 |
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | Acell, Inc. | 2024-07-11 | 27 | 0 |
| K241706 | MicroMatrix® UBM Particulate | Acell, Inc. | 2024-07-11 | 28 | 0 |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-04-25 | 226 | 0 |
| K232204 | ReyaGel (RG03 - MTP gel 3mL) | Fettech | 2024-04-19 | 269 | 0 |
| K240753 | Miro3D Fibers Wound Matrix | Reprise Biomedical, Inc. | 2024-04-19 | 30 | 0 |
| K240277 | MiroDry Wound Matrix | Reprise Biomedical, Inc. | 2024-03-01 | 30 | 0 |
| K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | 2024-02-02 | 270 | 0 |
| K231614 | MiroTract Wound Matrix | Reprise Biomedical, Inc. | 2023-12-13 | 194 | 0 |
| K232758 | Comatryx OTC | Strukmyer Medical, LLC | 2023-12-01 | 84 | 0 |
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023-11-13 | 136 | 0 |
| K231152 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2023-10-12 | 171 | 0 |
| K223126 | SurgiAid® Collagen Wound Dressing | Maxigen Biotech, Inc. | 2023-10-11 | 373 | 0 |
| K230980 | MicroMatrix® Flex | Acell, Inc. | 2023-09-22 | 170 | 0 |
| K212766 | Maxiocel Chitosan Wound Dressing | Advamedica, Inc. | 2023-08-24 | 723 | 0 |
| K220498 | NovoGen Wound Matrix | Novabone Products, LLC | 2023-06-09 | 472 | 0 |
| K212579 | FortiShield (Biosynthetic Wound Matrix) | Organogenesis, Inc. | 2023-05-02 | 624 | 0 |
| K223257 | Miro3D Wound Matrix | Reprise Biomedical | 2022-11-21 | 31 | 0 |
| K213716 | InnovaBurn | Triad Life Sciences, Inc. | 2022-09-29 | 309 | 0 |
| K211902 | InnovaMatrix PD | Triad Life Sciences, Inc. | 2022-09-28 | 464 | 0 |
| K213598 | LUOFUCON Collagen Wound Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2022-09-20 | 309 | 0 |
| K221520 | Miro3D Wound Matrix | Reprise Biomedical, Inc. | 2022-08-18 | 85 | 0 |
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022-08-11 | 499 | 0 |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | Gunze Limited | 2022-07-14 | 255 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda