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/submissions/SU/subpart-e%E2%80%94surgical-devices/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 209) Showing 20 most recent of 209 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253429](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K253429.md) | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | Mar 12, 2026 | SESE | | [K250586](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K250586.md) | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | Nov 21, 2025 | SESE | | [K251646](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K251646.md) | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | Oct 3, 2025 | SESE | | [K251826](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K251826.md) | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | Sep 11, 2025 | SESE | | [K243187](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K243187.md) | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | Jun 27, 2025 | SESE | | [K243576](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K233614.md) | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | Dec 23, 2024 | SESE | | [K241061](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K241061.md) | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | Aug 21, 2024 | SESE | | [K241023](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K241023.md) | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | Aug 19, 2024 | SESE | | [K241515](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K241515.md) | NEXA™ NPWT System | Nexa Medical Limited | Jul 26, 2024 | SESE | | [K231939](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K231939.md) | Renasys Edge | Smith & Nephew Medical, Ltd. | May 24, 2024 | SESE | | [K241134](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K241134.md) | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | May 23, 2024 | SESE | | [K230233](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K230233.md) | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | Apr 18, 2024 | SESE | | [K231646](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K231646.md) | Carilex VT¿200-i NX | Carilex Medical, Inc. | Apr 17, 2024 | SESE | | [K232379](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K232379.md) | PREVENT Kit | Clear Choice Therapeutics | Feb 5, 2024 | SESE | | [K230677](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K230677.md) | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | Dec 6, 2023 | SESE | | [K223388](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K223388.md) | Invia® Integrated Dressing | Medela AG | Jul 7, 2023 | SESE | | [K221888](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K221888.md) | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | Jun 12, 2023 | SESE | | [K222859](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K222859.md) | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) | 3M | Mar 23, 2023 | SESE | | [K221585](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K221585.md) | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit | 3M Healthcare Business Group | Mar 23, 2023 | SESE | ## Top Applicants - Kci USA, Inc. — 26 clearances - Smith & Nephew, Inc. — 14 clearances - Smith & Nephew Medical Limited — 14 clearances - Genadyne Biotechnologies, Inc. — 14 clearances - Medela AG — 13 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/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