OMP
- Product code
- OMP
- Device name
- Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4780
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 21
- Summaries archived here
- 19 (direct download)
- 510(k) clearances (all years, FDA)
- 214 (all years; only the last 3 years are listed here)
FDA classification definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253263 | 2026-06-24 | Convatec Limited, Gdc Building | ConvaVAC Negative Pressure Wound Therapy System | FDA |
| K253199 | 2026-06-23 | CG Bio Co., Ltd. | CURASYS 2 (EMDN0003) | |
| K260646 | 2026-05-27 | Smith & Nephew Medical, Ltd. | RENASYS EDGE (66803126) | |
| K261291 | 2026-05-21 | Cork Medical | Nisus NPWT Canister 500-mL (CPC-500) | |
| K254019 | 2026-05-04 | Bechtel Medical, Inc. | Wound Geni NPWT System | |
| K253429 | 2026-03-12 | Genadyne Biotechnologies, Inc. | Genadyne ASTRA NPWT | |
| K250586 | 2025-11-21 | Deroyal Industries, Inc. | Prospera Spectruum Negative Pressure Wound Therapy B… | |
| K251646 | 2025-10-03 | Alleva Medical Devices | extriCARE® 1000 Negative Pressure Wound Therapy Syst… | |
| K251826 | 2025-09-11 | Smith & Nephew Medical, Ltd. | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | |
| K243187 | 2025-06-27 | Cork Medical | Nisus ONE Negative Pressure Wound Therapy System (OC… | |
| K243576 | 2025-02-18 | Smith & Nephew Medical, Ltd. | RENASYS Foam Wound Dressing Kit with AIRLOCK Technol… | |
| K233614 | 2024-12-23 | Genadyne Biotechnologies, Inc. | Genadyne DUO NPWT | |
| K241061 | 2024-08-21 | Cork Medical | VERSA Negative Pressure Wound Therapy System (VCMPP-… | FDA |
| K241023 | 2024-08-19 | Med Way, Inc. | Negative Pressure Wound Therapy Device (V-Move, V-Gr… | |
| K241515 | 2024-07-26 | Nexa Medical Limited | NEXA NPWT System | |
| K231939 | 2024-05-24 | Smith & Nephew Medical, Ltd. | Renasys Edge | |
| K241134 | 2024-05-23 | Kci USA, Inc. | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/… | |
| K230233 | 2024-04-18 | Deroyal Industries, Inc. | Prospera Spectruum Negative Pressure Wound Therapy S… | |
| K231646 | 2024-04-17 | Carilex Medical, Inc. | Carilex VT¿200-i NX | |
| K232379 | 2024-02-05 | Clear Choice Therapeutics | PREVENT Kit | |
| K230677 | 2023-12-06 | Cork Medical | Cork Medical VERSA Negative Pressure Wound System (V… |
Official FDA classification page: OMP
Classification and pathway per current FDA publications. Data from openFDA (CC0).