# K221494: Quality Mix Blender, Oxymixer

- Pathway: 510(k) (Traditional)
- Applicant: Dehas Medical Systems GmbH
- Decided: Jan 23, 2023 after 245 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 5.

## Indications for use
The air-oxygen mixer Quality Mix is used to administer a continuous, precise mix of medical air and medical oxygen – through its outlet ports – to infants, children and adults. The exact fractional inspiratory oxygen concentration (FiO2) corresponds to the selected FiO2 setting on the control knob (dial). It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in professional healthcare settings. This product is not intended for use as a life supporting device. Warning: By using flows above 70 LPM, the risk of high flow such as air trapping, barotrauma, and gastric insufflation (leading to possible aspiration) can occur.

Source page: https://510kreport.com/device/K221494
Methodology: https://510kreport.com/methodology