# K222644: Nihon Kohden NKV-440 Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Orangemed, Inc.
- Decided: May 31, 2023 after 272 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K093633 (2010). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192307: Nihon Kohden NKV-550 Series Ventilator System, Nihon Kohden Orangemed, Inc. (2020) Summary page 5.

## Most influential descendants
- K251165: Saans (F4-01-00-000-000) (2026), 0 descendants of its own

## Indications for use
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

Source page: https://510kreport.com/device/K222644
Methodology: https://510kreport.com/methodology