# K192307: Nihon Kohden NKV-550 Series Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Orangemed, Inc.
- Decided: Jan 10, 2020 after 137 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K093633 (2010). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181695: Nihon Kohden NKV-550 Series Ventilator System, Nihon Kohden Orangemed, Inc. (2018) Summary page 4.

## Most influential descendants
- K222644: Nihon Kohden NKV-440 Ventilator System (2023), 1 descendant of its own
- K251165: Saans (F4-01-00-000-000) (2026), 0 descendants of its own
- K231778: Nihon Kohden NKV-550 Series Ventilator System (2024), 0 descendants of its own

## Recalls of this device
- Jul 20, 2021 · Class II · Z-2435-2021: 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,

## Indications for use
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

Source page: https://510kreport.com/device/K192307
Methodology: https://510kreport.com/methodology