# K162603: Masimo O3 Regional Oximeter System

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: May 26, 2017 after 249 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931154 (1993). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160526: Masimo O3 Regional Oximeter System, Masimo Corporation (2016) Summary page 4.
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 4.

## Indications for use
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and < 40 kg in healthcare environments.

Source page: https://510kreport.com/device/K162603
Methodology: https://510kreport.com/methodology