# K974372: Air Oxyge Mixer

- Pathway: 510(k) (Traditional)
- Applicant: Sk Med
- Decided: Feb 5, 1998 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bird Low Flow Air/Oxygen Microblender: named in the summary without a submission number

## Indications for use
The SK Med Air Oxygen Mixer is intended for use with the infant and pediatric population in a hospital environment. Its indications for use are exactly the same as the predicate device i.e. the Bird Low Flow Air Microblender. It is used to provide oxygen therapy in conjunction with: Oxygen Hoods Resuscitation Bags Masks Nasal Cannulas

Source page: https://510kreport.com/device/K974372
Methodology: https://510kreport.com/methodology