# K024228: RX300 Oxygen Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Teledyne Analytical Instruments
- Decided: Jul 17, 2003 after 206 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AX300 is intended to accurately measure (spot check) and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

Source page: https://510kreport.com/device/K024228
Methodology: https://510kreport.com/methodology