Product code OMP
- Device name
- Negative Pressure Wound Therapy Powered Suction Pump
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4780
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026-05-21 |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026-05-04 |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | 2026-03-12 |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | 2025-11-21 |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | 2025-10-03 |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | 2025-09-11 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | 2025-06-27 |
| 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. | 2025-02-18 |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024-12-23 |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | 2024-08-21 |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | 2024-08-19 |
| K241515 | NEXA™ NPWT System | Nexa Medical Limited | 2024-07-26 |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024-05-24 |
| K241134 | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | 2024-05-23 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | 2024-04-18 |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024-04-17 |
| K232379 | PREVENT Kit | Clear Choice Therapeutics | 2024-02-05 |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | 2023-12-06 |
| K223388 | Invia® Integrated Dressing | Medela AG | 2023-07-07 |
| K221888 | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | 2023-06-12 |
| K222859 | 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 | 2023-03-23 |
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit | 3M Healthcare Business Group | 2023-03-23 |
| K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical, Ltd. | 2023-03-08 |
| K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large | Smith and Nephew Medical Limited | 2023-02-10 |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | 2023-02-09 |
| K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022-12-14 |
| K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022-11-22 |
| K212359 | PWD Negative Pressure Wound Therapy System | Applied Tissue Technologies, LLC | 2022-09-21 |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | Medela AG | 2022-07-26 |
| K220560 | Dermatac Drape | 3M | 2022-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00197998382895 | Solventum™ Veraflo™ Cleanse Choice™ | Solventum US LLC | 2026-05-28 |
| 00197998382819 | Solventum™ Veraflo™ Cleanse Choice™ | Solventum US LLC | 2026-05-28 |
| 08718104890947 | Endo-SPONGE Pump | Meditop B.V. | 2025-10-17 |
| 07612367016940 | Invia Liberty Carrying Case | Medela AG | 2024-10-11 |
| 07612367060509 | Invia Motion Carrying Case | Medela AG | 2024-10-11 |
| 07612367038713 | Standard rail universal holder | Medela AG | 2024-06-03 |
| 07612367078009 | Invia Integrated Dressing | Medela AG | 2023-07-20 |
| 07612367077996 | Invia Integrated Dressing | Medela AG | 2023-07-20 |
| 07612367077972 | Invia Integrated Dressing | Medela AG | 2023-07-20 |
| 10192253011364 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-03-19 |
| 10192253011401 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-25 |
| 10192253011395 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-25 |
| 10192253011388 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-25 |
| 10192253011371 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-25 |
| 10192253011357 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-25 |
| 07612367054003 | Invia Abdominal Dressing Kit | Medela AG | 2019-02-13 |
| 07612367050142 | Invia Gauze Dressing Kit | Medela AG | 2017-06-07 |
| 07612367050173 | Invia Gauze Dressing Kit | Medela AG | 2017-06-07 |
| 07612367050227 | Invia Transparent Film | Medela AG | 2017-06-07 |
| 07612367050128 | Invia Foam Dressing Kit | Medela AG | 2017-06-07 |
| 07612367050098 | Invia Foam Dressing Kit | Medela AG | 2017-06-07 |
| 07612367050067 | Invia Foam Dressing Kit | Medela AG | 2017-06-07 |
| 07612367050005 | Invia Foam Dressing Kit | Medela AG | 2017-06-07 |
| 07612367049603 | Invia Fitpad | Medela AG | 2017-06-07 |
| 07612367015462 | Invia Liberty canister 0.8l | Medela AG | 2017-01-20 |
| 07612367015455 | Invia Liberty canister 0.3l | Medela AG | 2017-01-20 |
| 07612367041201 | Invia Liberty Y-Connector with quick connector | Medela AG | 2016-10-03 |
| 07612367041195 | Invia Drain Adapter | Medela AG | 2016-10-03 |
| 07612367041188 | Invia Liberty Tubing with quick connector | Medela AG | 2016-10-03 |
| 07612367024426 | Docking Station | Medela AG | 2016-10-03 |