Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4780](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4780) → OMP — Negative Pressure Wound Therapy Powered Suction Pump

# OMP · Negative Pressure Wound Therapy Powered Suction Pump

_General, Plastic Surgery · 21 CFR 878.4780 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/OMP

## Overview

- **Product Code:** OMP
- **Device Name:** Negative Pressure Wound Therapy Powered Suction Pump
- **Regulation:** [21 CFR 878.4780](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4780)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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](/device/K260646.md) | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | May 27, 2026 | SESE |
| [K261291](/device/K261291.md) | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | May 21, 2026 | SESE |
| [K254019](/device/K254019.md) | Wound Geni NPWT System | Bechtel Medical, Inc. | May 4, 2026 | SESE |
| [K253429](/device/K253429.md) | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | Mar 12, 2026 | SESE |
| [K250586](/device/K250586.md) | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | Nov 21, 2025 | SESE |
| [K251646](/device/K251646.md) | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | Oct 3, 2025 | SESE |
| [K251826](/device/K251826.md) | RENASYS WOUND+  Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | Sep 11, 2025 | SESE |
| [K243187](/device/K243187.md) | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | Jun 27, 2025 | SESE |
| [K243576](/device/K243576.md) | 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](/device/K233614.md) | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | Dec 23, 2024 | SESE |
| [K241061](/device/K241061.md) | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | Aug 21, 2024 | SESE |
| [K241023](/device/K241023.md) | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | Aug 19, 2024 | SESE |
| [K241515](/device/K241515.md) | NEXA™ NPWT System | Nexa Medical Limited | Jul 26, 2024 | SESE |
| [K231939](/device/K231939.md) | Renasys Edge | Smith & Nephew Medical, Ltd. | May 24, 2024 | SESE |
| [K241134](/device/K241134.md) | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | May 23, 2024 | SESE |
| [K230233](/device/K230233.md) | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | Apr 18, 2024 | SESE |
| [K231646](/device/K231646.md) | Carilex VT¿200-i NX | Carilex Medical, Inc. | Apr 17, 2024 | SESE |
| [K232379](/device/K232379.md) | PREVENT Kit | Clear Choice Therapeutics | Feb 5, 2024 | SESE |
| [K230677](/device/K230677.md) | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | Dec 6, 2023 | SESE |
| [K223388](/device/K223388.md) | 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

---

**Source:** [https://fda.innolitics.com/productcode/OMP](https://fda.innolitics.com/productcode/OMP)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com