Nisus ONE Npwt System
The Nisus ONE is a powered suction pump for negative pressure wound therapy. Used with the Cork NPWT Wound Dressing Kit, it applies suction through the dressing to remove wound exudate into…
The Nisus ONE is a powered suction pump for negative pressure wound therapy. Used with the Cork NPWT Wound Dressing Kit, it applies suction through the dressing to remove wound exudate into a collection canister. It is suitable for professional healthcare facilities and home use.
A single button controls the pump and switches between continuous and intermittent modes. Continuous therapy defaults to 125 mmHg; intermittent therapy alternates between 125 and 40 mmHg. The display shows the therapy mode, battery status and target pressure.
Listed Item
Nisus ONE Negative Pressure Wound Therapy powered suction pump
Canisters and Alarms
The system uses compatible 250 or 500 mL Nisus collection canisters. Visual and audible alarms notify the user of critical battery status, pressure leakage, blockage and a full canister. A charger is provided for the pump.
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | Cork Medical, LLC, United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K243187 |
| Record published | 2026-04-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OCMPP-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261291 | 2026-05-21 |
| K243187 | 2025-06-27 |
| K241061 | 2024-08-21 |
| K230677 | 2023-12-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.