OMP · Negative Pressure Wound Therapy Powered Suction Pump
General, Plastic Surgery · 21 CFR 878.4780 · Class 2
Overview
| Product Code | OMP |
|---|---|
| Device Name | Negative Pressure Wound Therapy Powered Suction Pump |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 212)
Showing 20 most recent of 212 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | May 27, 2026 | SESE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | May 21, 2026 | SESE |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | May 4, 2026 | SESE |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | Mar 12, 2026 | SESE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | Nov 21, 2025 | SESE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | Oct 3, 2025 | SESE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | Sep 11, 2025 | SESE |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | Jun 27, 2025 | SESE |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical, Ltd. | Feb 18, 2025 | SESE |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | Dec 23, 2024 | SESE |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | Aug 21, 2024 | SESE |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | Aug 19, 2024 | SESE |
| K241515 | NEXA™ NPWT System | Nexa Medical Limited | Jul 26, 2024 | SESE |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | May 24, 2024 | SESE |
| K241134 | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | May 23, 2024 | SESE |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | Apr 18, 2024 | SESE |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | Apr 17, 2024 | SESE |
| K232379 | PREVENT Kit | Clear Choice Therapeutics | Feb 5, 2024 | SESE |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | Dec 6, 2023 | SESE |
| K223388 | Invia® Integrated Dressing | Medela AG | Jul 7, 2023 | SESE |
Top Applicants
- Kci USA, Inc. — 26 clearances
- Genadyne Biotechnologies, Inc. — 14 clearances
- Smith & Nephew Medical Limited — 14 clearances
- Smith & Nephew, Inc. — 14 clearances
- Kci USA, Inc. (Kinetic Concepts, Inc.) — 13 clearances
