Nihon Kohden NKV-550 Series Ventilator System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192307 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NKV-550 Series Ventilator System is a Facility-Use Ventilator, Continuous (per FDA classification), designed for mechanical ventilation of adult, pediatric, and neonatal patients. It delivers invasive, non-invasive ventilation, and high-flow oxygen therapy through a single platform, supporting lung-protective strategies with customizable settings. The device integrates advanced respiratory care modalities to adapt to varying patient needs across different clinical settings.
This ventilator system is intended for use in hospital or clinical environments and is supplied as a reusable medical device. It operates within MRI-safe parameters as defined by its regulatory submissions and is authorized for use in the United States under FDA 510K clearance (K192307). The NKV-550 Series adheres to Class II device classification and is regulated under 21 CFR 868.5895. Storage and maintenance instructions are manufacturer-specific and must be followed to ensure proper functionality and sterility.
Frequently asked questions
What patient populations is the NKV-550 Series Ventilator System designed for?
The NKV-550 Series Ventilator System is specifically designed for mechanical ventilation of three distinct patient populations: adults, pediatric patients, and neonates. This versatility allows it to be used across a broad range of clinical settings, from intensive care units to neonatal wards, ensuring tailored respiratory support for varying patient needs.
What types of ventilation does the NKV-550 Series provide?
The NKV-550 Series Ventilator System provides both invasive and non-invasive ventilation, along with high-flow oxygen therapy. This single-platform solution integrates multiple respiratory care modalities to adapt to different patient requirements, supporting lung-protective ventilation strategies.
Is the NKV-550 Series Ventilator System reusable or single-use?
The NKV-550 Series Ventilator System is classified as a reusable medical device. It is intended for use in hospital or clinical environments, where proper storage, maintenance, and cleaning protocols must be followed to ensure functionality and sterility between uses.
Does the NKV-550 Series Ventilator System operate within MRI-safe parameters?
Yes, the NKV-550 Series Ventilator System is designed to operate within MRI-safe parameters as defined by its regulatory submissions. This feature allows for safe use in clinical environments where MRI compatibility is required, reducing the risk of interference or safety hazards.
What regulatory approval does the NKV-550 Series Ventilator System hold in the United States?
The NKV-550 Series Ventilator System is authorized for use in the United States under FDA 510K clearance (K192307). It adheres to Class II device classification and is regulated under 21 CFR 868.5895. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.
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-550 Series Ventilator System - NIHON KOHDEN GLOBAL, 550 Ventilator | Nihon Kohden OrangeMed, NKV-550 Ventilation System - Nihon Kohden Europe, Illuminating Medicine - Nihon Kohden Europe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192307 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Orangemed, Inc.
Sources (1)
- FDA 510(k) K192307 24 fields · synced Oct 1, 2026