# K213521: Nihon Kohden NKV-330 Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Orangemed, Inc.
- Decided: Jul 1, 2022 after 240 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- 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: 6 generations back to K833786 (1983). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102985: V60 Ventilator with PPV and Auto-Trak+ Software Options, Respironics, Inc. (2011) Summary page 4.

## Most influential descendants
- K252182: SV70 Ventilator (SV70) (2026), 0 descendants of its own
- K242931: HFT750U (2025), 0 descendants of its own

## Indications for use
The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospitals, hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.

Source page: https://510kreport.com/device/K213521
Methodology: https://510kreport.com/methodology