# K202480: Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

- Pathway: 510(k) (Traditional)
- Applicant: Parker Hannifin
- Decided: Apr 22, 2021 after 237 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760766 (1976). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760766: Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer, Fraser Sweatman, Inc. (1976) Summary page 4.

## Indications for use
The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.

Source page: https://510kreport.com/device/K202480
Methodology: https://510kreport.com/methodology