Nihon Kohden
The Nihon Kohden NKV-550 Series is a ventilator family with a graphical control interface and a breath-delivery unit. The interface displays monitored values and waveforms, while the…
The Nihon Kohden NKV-550 Series is a ventilator family with a graphical control interface and a breath-delivery unit. The interface displays monitored values and waveforms, while the delivery unit controls the pneumatic system that supplies breaths.
A microprocessor links the electronic controls to breath delivery. Clinicians set ventilation parameters and alarm limits at the interface, with the system supporting mandatory and spontaneous modes for invasive or noninvasive respiratory support.
Listed Item
The Nihon Kohden NKV-550-N is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through pediatric patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
Gas and Care Configurations
The series uses medical oxygen and compressed medical air, with oxygen concentration settings from 21 to 100 percent. Its patient configurations include adult, pediatric and neonatal support in hospitals and during transport within the hospital.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Nihon Kohden Orangemed, LLC, United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181695 |
| Record published | 2020-03-27 |
| Record revised | 2024-07-26 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Special storage condition: Altitude: 6096 meters (maximum); Storage environment humidity 10 to 95 % RH; Storage environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSP5500A | In distribution | |
| NKV-440 | In distribution | |
| NKV-550-S | In distribution | |
| NKV-550-N | In distribution | |
| NKV-440 | In distribution | |
| NKV-550-U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231778 | 2024-03-01 |
| K222644 | 2023-05-31 |
| K192307 | 2020-01-10 |
| K181695 | 2018-12-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nihon Kohden Orangemed, LLC | 510(k) number | 2021-07-20 | Class II | Nonconforming Material/Component | Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior t | 1,999 units | 2023-04-21 |
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.