Nihon Kohden NKV-440 Ventilator System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Nihon Kohden NKV-440 Ventilator System EUDAMEDNihon Kohden FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- Nihon Kohden NKV-440 Ventilator System EUDAMEDFDA UDINihon Kohden NKV-440 Ventilator System with SpO2/CO2 FDA UDI
- Model / Reference
- NKV-440 EUDAMEDFDA UDI
- Description
- Nihon Kohden NKV-440 Ventilator System with SpO2/CO2 FDA UDINihon Kohden NKV-440 Ventilator System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843685100166 EUDAMEDFDA UDI00843685100159 EUDAMEDFDA UDI
- Basic UDI-DI
- 08436851NKV440JX EUDAMED
- Direct Marketing DI
- 00843685100159 EUDAMED00843685100166 EUDAMED
- 510(k) Number
- FDA Product Code
- CBK FDA 510(k)FDA UDI
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Nihon Kohden NKV-440 Ventilator System is a continuous, facility-use ventilator designed for invasive and non-invasive mechanical ventilation. It supports neonatal through adult patients and integrates high-flow oxygen therapy, providing advanced respiratory support in critical care settings. The device is classified as a Class II medical device and operates as a turbine-driven ventilator, enabling precise control of ventilation parameters for diverse patient needs.
The NKV-440 is intended for use in intensive care units (ICUs) and other clinical environments requiring continuous respiratory support. It is supplied as a reusable device, with regulatory authorizations including FDA 510(k) clearance and MDR compliance. The system is optimized for seamless transitions between invasive and non-invasive ventilation modes, including high-flow therapy, and is equipped for facility-based deployment. No specific MRI safety classification or single-use indications are stated in the device data.
Frequently asked questions
What patient populations can the NKV-440 Ventilator System support, and how does it handle transitions between ventilation modes?
The NKV-440 Ventilator System is designed to provide continuous mechanical ventilation for patients ranging from neonatal through adult. It supports both invasive and non-invasive ventilation modes, including high-flow oxygen therapy, and is optimized for seamless transitions between these modes. This versatility makes it suitable for critical care settings where patient needs may change rapidly, such as intensive care units (ICUs).
Is the NKV-440 Ventilator System intended for single-use or reusable applications, and what does this mean for maintenance?
The NKV-440 Ventilator System is explicitly described as a reusable device, meaning it is designed for facility-based use rather than disposable applications. This implies that it requires regular cleaning, disinfection, and maintenance as part of its operational lifecycle, ensuring reliability and compliance with hospital infection control protocols.
What regulatory pathways has the NKV-440 Ventilator System followed, and how does this affect its deployment?
The NKV-440 has obtained FDA 510(k) clearance and MDR compliance, confirming its regulatory authorization for use in the United States and European markets, respectively. These pathways validate its safety and performance for facility-based ventilation, ensuring it meets stringent standards for critical care environments. The device’s classification as Class II further underscores its role in specialized medical settings.
Does the NKV-440 Ventilator System include any specialized features for high-flow oxygen therapy, and how does this benefit patients?
Yes, the NKV-440 is explicitly designed to integrate high-flow oxygen therapy, which delivers precise and elevated oxygen concentrations to patients. This feature is particularly beneficial for conditions requiring advanced respiratory support, such as acute respiratory distress syndrome (ARDS) or post-operative care, where maintaining optimal oxygenation is critical. The system’s turbine-driven mechanism enables fine-tuned control of ventilation parameters, enhancing patient outcomes.
What types of clinical environments is the NKV-440 Ventilator System intended for, and how does its design accommodate diverse patient needs?
The NKV-440 is intended for intensive care units (ICUs) and other clinical environments requiring continuous respiratory support. Its design supports neonatal through adult patients, offering flexibility in ventilation modes (invasive and non-invasive) and high-flow oxygen therapy. This adaptability ensures it can address a broad spectrum of critical care scenarios, from pediatric to adult critical illness, while maintaining seamless transitions between treatment modalities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NKV-440 Series Ventilator System - NIHON KOHDEN GLOBAL, 440 Ventilator | Nihon Kohden OrangeMed, NKV-440 Ventilation System - Nihon Kohden Europe, Nihon Kohden NKV-440 Ventilator | RT - respiratory-therapy.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222644 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Orangemed, Inc.
Sources (5)
- FDA 510(k) K222644 24 fields · synced Sep 20, 2026
- FDA UDI d564af39-e1e0-435d-a7ef-b47b2e552ceb 36 fields · synced May 29, 2026
- FDA UDI 99e47a46-4629-42d2-aa5c-f787486105aa 36 fields · synced May 30, 2026
- EUDAMED 99e81c6d-0cf4-4e5b-8431-9717f744e21b 61 fields · synced Jul 23, 2026
- EUDAMED b8fa0958-11e2-4aca-8276-2624781e0bd1 61 fields · synced Jul 24, 2026