Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMP — Predicate Candidate Screening
214 FDA 510(k) clearances under this product code; the 50 most recent screened below.
172 daysmedian FDA review time
373 days90th percentile
214clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253263 | ConvaVAC™ Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | 2026-06-24 | 268 | 0 |
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | 2026-06-23 | 270 | 0 |
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | 2026-05-27 | 89 | 0 |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026-05-21 | 31 | 0 |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026-05-04 | 140 | 0 |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | 2026-03-12 | 162 | 0 |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foa | Deroyal Industries, Inc. | 2025-11-21 | 267 | 0 |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | 2025-10-03 | 127 | 0 |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | 2025-09-11 | 90 | 0 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | 2025-06-27 | 270 | 0 |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and | Smith & Nephew Medical, Ltd. | 2025-02-18 | 91 | 0 |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024-12-23 | 406 | 0 |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | 2024-08-21 | 125 | 0 |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | 2024-08-19 | 126 | 0 |
| K241515 | NEXA™ NPWT System | Nexa Medical Limited | 2024-07-26 | 58 | 0 |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024-05-24 | 329 | 0 |
| K241134 | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275 | Kci USA, Inc. | 2024-05-23 | 29 | 0 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | 2024-04-18 | 447 | 0 |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024-04-17 | 317 | 0 |
| K232379 | PREVENT Kit | Clear Choice Therapeutics | 2024-02-05 | 181 | 0 |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100 | Cork Medical | 2023-12-06 | 271 | 0 |
| K223388 | Invia® Integrated Dressing | Medela AG | 2023-07-07 | 242 | 0 |
| K221888 | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | 2023-06-12 | 348 | 0 |
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cl | 3M Healthcare Business Group | 2023-03-23 | 295 | 0 |
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V | 3M | 2023-03-23 | 182 | 0 |
| K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical, Ltd. | 2023-03-08 | 449 | 0 |
| K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF Whit | Smith and Nephew Medical Limited | 2023-02-10 | 427 | 0 |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | 2023-02-09 | 287 | 0 |
| K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022-12-14 | 168 | 0 |
| K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022-11-22 | 54 | 3 |
| K212359 | PWD Negative Pressure Wound Therapy System | Applied Tissue Technologies, LLC | 2022-09-21 | 419 | 0 |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | Medela AG | 2022-07-26 | 208 | 0 |
| K220560 | Dermatac Drape | 3M | 2022-07-14 | 136 | 0 |
| K220660 | Prevena Restor Adapti-Form Dressing | 3M Healthcare Business Group | 2022-07-01 | 116 | 0 |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy Sys | Genadyne Biotechnologies, Inc. | 2022-06-01 | 502 | 0 |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large | Zhejiang Longterm Medical Technology Co., Ltd. | 2022-05-31 | 375 | 0 |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Tr | Smith & Nephew Medical Limited | 2022-01-14 | 479 | 0 |
| K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PI | Smith Nephew Medical Limited | 2022-01-05 | 250 | 0 |
| K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System | Lightstone Medical Products (Ningbo) Co, Ltd. | 2021-12-30 | 457 | 0 |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dres | 3M Healthcare Business Group | 2021-12-20 | 217 | 0 |
| K211277 | Theia NPWT Foam Wound Dressing Kit | Clear Choice Therapeutics, Inc. | 2021-12-16 | 233 | 0 |
| K202823 | Innomed NPWT Silicone Foam Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2021-12-15 | 447 | 0 |
| K203316 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci, A Part of 3M Health Care Business Group | 2021-10-27 | 351 | 0 |
| K212320 | Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring Sen | 3M Healthcare Business Group | 2021-09-28 | 64 | 0 |
| K203693 | Nisus Touch Negative Pressure Wound Therapy Pump | Cork Medical Products, LLC | 2021-08-13 | 238 | 0 |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | Molnlycke Health Care Us, LLC | 2021-07-01 | 227 | 0 |
| K202217 | Kendall NPWT Incision Management Device | Cardinalhealth | 2021-06-04 | 302 | 0 |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PI | Smith & Nephew Medical Limited | 2020-10-30 | 88 | 0 |
| K200223 | PocketDoc™ Micro Wound Therapy System | Pensar Medical, LLC | 2020-10-23 | 268 | 0 |
| K191101 | Kendall NPWT Incision Management Dressing Kit | Cardinalhealth | 2020-07-31 | 463 | 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