OMP — Negative Pressure Wound Therapy Powered Suction Pump Class II
FDA product code OMP covers "Negative Pressure Wound Therapy Powered Suction Pump", a Class II medical device regulated under 21 CFR 878.4780. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OMP
- Device Class
- Class II
- Regulation Number
- 878.4780
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261338 | Smith And Nephew Medical | RENASYS DYNAFLOW Kit (66807741) | Sep 11, 2026 |
| K253263 | Convatec Limited, Gdc Building | ConvaVAC Negative Pressure Wound Therapy System | Jun 24, 2026 |
| K253199 | Cg Bio Co | CURASYS 2 (EMDN0003) | Jun 23, 2026 |
| K260646 | Smith And Nephew Medical | RENASYS EDGE (66803126) | May 27, 2026 |
| K261291 | Cork Medical | Nisus NPWT Canister 500-mL (CPC-500) | May 21, 2026 |
| K254019 | Bechtel Medical | Wound Geni NPWT System | May 4, 2026 |
| K253429 | Genadyne Biotechnologies | Genadyne ASTRA NPWT | Mar 12, 2026 |
| K250586 | Deroyal Industries | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa | Nov 21, 2025 |
| K251646 | Alleva Medical Devices | extriCARE® 1000 Negative Pressure Wound Therapy System | Oct 3, 2025 |
| K251826 | Smith And Nephew Medical | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Sep 11, 2025 |
| K243187 | Cork Medical | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Jun 27, 2025 |
| K243576 | Smith And Nephew Medical | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS G | Feb 18, 2025 |
| K233614 | Genadyne Biotechnologies | Genadyne DUO NPWT | Dec 23, 2024 |
| K241061 | Cork Medical | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Aug 21, 2024 |
| K241023 | Med Way | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Aug 19, 2024 |
| K241515 | Nexa Medical Limited | NEXA NPWT System | Jul 26, 2024 |
| K231939 | Smith And Nephew Medical | Renasys Edge | May 24, 2024 |
| K241134 | Kci Usa | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | May 23, 2024 |
| K230233 | Deroyal Industries | Prospera Spectruum Negative Pressure Wound Therapy System | Apr 18, 2024 |
| K231646 | Carilex Medical | Carilex VT¿200-i NX | Apr 17, 2024 |