OMP — Negative Pressure Wound Therapy Powered Suction Pump Class II
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 |
|---|---|---|---|
| K253429 | genadyne biotechnologies | Genadyne ASTRA NPWT | March 12, 2026 |
| K250586 | deroyal industries | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa | November 21, 2025 |
| K251646 | alleva medical devices | extriCARE® 1000 Negative Pressure Wound Therapy System | October 3, 2025 |
| K251826 | smith and nephew medical | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | September 11, 2025 |
| K243187 | cork medical | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | June 27, 2025 |
| K243576 | smith and nephew medical | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS G | February 18, 2025 |
| K233614 | genadyne biotechnologies | Genadyne DUO NPWT | December 23, 2024 |
| K241061 | cork medical | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | August 21, 2024 |
| K241023 | med way | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | August 19, 2024 |
| K241515 | nexa medical limited | NEXA NPWT System | July 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 | April 18, 2024 |
| K231646 | carilex medical | Carilex VT¿200-i NX | April 17, 2024 |
| K232379 | clear choice therapeutics | PREVENT Kit | February 5, 2024 |
| K230677 | cork medical | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | December 6, 2023 |
| K223388 | medela | Invia® Integrated Dressing | July 7, 2023 |
| K221888 | genadyne biotechnologies | Genadyne Hybrid Foam Dressings | June 12, 2023 |
| K222859 | 3m | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place | March 23, 2023 |
| K221585 | 3m healthcare business group | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complet | March 23, 2023 |