Cardinal Health NPWT PRO HC
FDA 510(k) K150124 · Cardinalhealth
510(k) numberK150124
Submission
- Device name
- Cardinal Health NPWT PRO HC
- Applicant
- Cardinalhealth
Waukegan, IL, US - Received
- January 20, 2015
- Decision date
- September 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code OMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs… · Traditional | 09/02/2026SE |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended CuffLZC · Traditional | 01/14/2026SE |
| K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe…FMF · Traditional | 08/22/2025SE |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with…PNR · Special | 12/19/2024SE |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health…FXX · Abbreviated | 07/03/2023SE |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 05/19/2022SE |
| K202217 | Kendall NPWT Incision Management DeviceOMP · Traditional | 06/04/2021SE |
| K191101 | Kendall NPWT Incision Management Dressing KitOMP · Traditional | 07/31/2020SE |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 11/07/2019SE |
| K171499 | Occlusion Detection Dressing KitOMP · Traditional | 09/22/2017SE |
Questions and answers
When was Cardinal Health NPWT PRO HC cleared by the FDA?
Cardinal Health NPWT PRO HC (K150124) received a 510(k) decision of Substantially Equivalent on September 2, 2015, 225 days after the submission was received.
What is the product code of K150124?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.