Nihon Kohden NKV-550 Series Ventilator System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K181695Ref NKV-550-NModel NKV-550Ref NKV-550-S

by Nihon Kohden Orangemed, Inc.

Identity

Trade Name: Nihon Kohden NKV-550 Series Ventilator System EUDAMED
Nihon Kohden FDA UDI
Generic Name: Neonatal/adult intensive-care ventilator FDA UDI
Device Name: Nihon Kohden NKV-550 Series Ventilator System EUDAMED
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). FDA UDI
The Nihon Kohden NKV-550-S is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult 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). FDA UDI
Model / Reference: NKV-550-N EUDAMEDFDA UDI
NKV-550-S EUDAMEDFDA UDI
NKV-550 EUDAMED
Description: 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). FDA UDI
The Nihon Kohden NKV-550-S is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult 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). FDA UDI

Identifiers

Catalog Number: NKV-550-N FDA UDI
NKV-550-S FDA UDI
Primary DI / UDI-DI: 00843685100029 EUDAMEDFDA UDI
00843685100005 EUDAMEDFDA UDI
Basic UDI-DI: 08436851NKV550K7 EUDAMED
Direct Marketing DI: 00843685100029 EUDAMED
00843685100005 EUDAMED
510(k) Number: K181695 FDA 510(k)FDA UDI
K192307 FDA UDI
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 EUDAMED
Class 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

The NKV-550 Series Ventilator System is a facility-use mechanical ventilator designed for neonatal through adult patients. It delivers continuous respiratory support, including advanced ventilation modes and lung-protective strategies, to manage ventilation requirements across diverse clinical settings.

This system is intended for use in hospital environments and is supplied as a reusable medical device. It has been granted FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for ventilator safety and performance. The device operates within standard MRI safety guidelines for facility use and requires proper maintenance and storage as specified by the manufacturer.

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 OrangeMed, Nihon Kohden OrangeMed, NKV-550 Series Ventilator System Receives FDA 510(k) Clearance, January 10, 2020 Nihon Kohden OrangeMed, Inc. Sheryl Higgins ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K181695	Class II	Active

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Manufacturer

Manufacturer: Nihon Kohden Orangemed, Inc.

Sources (5)

FDA 510(k) K181695 24 fields · synced Sep 20, 2026
FDA UDI 08fb80c3-c899-4050-9f56-72039878a2ae 37 fields · synced May 29, 2026
FDA UDI 6c7364a9-b4c6-4a2a-9dca-c4e2d270fe31 37 fields · synced May 30, 2026
EUDAMED bdc78648-d217-408c-bafd-c14a484f8717 61 fields · synced Jul 23, 2026
EUDAMED 2b872726-b351-481e-8a32-80cd97b81e50 61 fields · synced Jul 30, 2026