# K142291: GMX Series Medical Air/Oxygen Blender

- Pathway: 510(k) (Traditional)
- Applicant: Gentec (Shanghai) Corporation
- Decided: May 19, 2015 after 274 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: 2 generations back to K925982 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053232: Precision Blender, Precision Medical, Inc. (2006) Summary page 4.

## Indications for use
The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.

Source page: https://510kreport.com/device/K142291
Methodology: https://510kreport.com/methodology