# K971084: Model 02 Oxygen Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Oxigraf, Inc.
- Decided: Jul 21, 1998 after 483 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
Longest line of descent: 2 generations back to K833326 (1983). 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)
- K961644: Miniox 3000 Oxygen Monitor, Minesafety Appliances Co. (1996) Summary page 1.
- K833326: Mini OX Iii Oxygen Monitor, Catalyst Research Corp. (1983) Summary page 1.

## Indications for use
The Model 02 is intended to provide continuous, direct patient monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia and breathing machines), respiratory therapy (e.g., breathing circuits, respirators, ventilators and pediatric incubators), and oxygen therapy (e.g., oxygen concentrators, tents, masks and nasal cannulas). The Model 02 is designed to be used by trained health care professionals under the supervision of a physician in a hospital, clinic, or emergency medicine setting.

Source page: https://510kreport.com/device/K971084
Methodology: https://510kreport.com/methodology