# K961644: Miniox 3000 Oxygen Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Minesafety Appliances Co.
- Decided: Jul 25, 1996 after 87 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: 1 generation back to K833326 (1983). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833326: Mini OX Iii Oxygen Monitor, Catalyst Research Corp. (1983) Summary page 2.

## Most influential descendants
- K991884: Siemens FIO2 Sensor (1999), 0 descendants of its own
- K971084: Model 02 Oxygen Analyzer (1998), 0 descendants of its own

## Indications for use
The MiniOX® 3000 Oxygen Monitor provides continuous, direct monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia machines), respiratory therapy (e.g., respirators, ventilators, pediatric incubators), and oxygen therapy (e.g., oxygen tents). The MiniOX® 3000 Oxygen Monitor is to be used by trained health care professionais under the supervision, or on the order, of a physician in a hospital (or other clinical setting) and during emergency transport.

Source page: https://510kreport.com/device/K961644
Methodology: https://510kreport.com/methodology