# K051192: Praxair Medical Air Mixer

- Pathway: 510(k) (Traditional)
- Applicant: Praxair, Inc.
- Decided: Sep 6, 2005 after 119 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 K031860 (2004). 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)
- K031860: SK Med ME202 Monitoring Mixer, Sk Med (2004) Summary page 1.

## Indications for use
The Praxair Medical Air mixer blends oxygen USP and nitrogen NF in order to provide Medical Air, USP having an oxygen concentration ranging between 19.5% and 23.5%. The device is to be used to supply Medical Air at a specific delivery pressure to the central supply system of a hospital/ healthcare facility for delivery through the hospital wall outlets to patients for purposes under the direction of a physician. The mixer will be located outside of the patient care area of the hospital, in a location such as the hospital mechanical room.

Source page: https://510kreport.com/device/K051192
Methodology: https://510kreport.com/methodology