# K231778: Nihon Kohden NKV-550 Series Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Orangemed, LLC
- Decided: Mar 1, 2024 after 259 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: 15 generations back to K902859 (1991). 102 ancestors in all.
No later device cites it as a predicate yet.
10 of 103 devices in its family (counting itself) have 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.
- K193228: Hamilton-G5, Hamilton Medical AG (2020) Summary page 5.

## 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/K231778
Methodology: https://510kreport.com/methodology