# K160526: Masimo O3 Regional Oximeter System

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jun 9, 2016 after 105 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: 13 generations back to K931154 (1993). 50 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133879: Fore-Sight Elite Absolute Tissue Oximeter, Cas Medical Systems, Inc. (2014) Summary page 4.

## Most influential descendants
- K182429: Masimo O3 Regional Oximeter System (2019), 3 descendants of its own
- K201432: Masimo O3 Regional Oximeter System (2020), 2 descendants of its own
- K214072: Masimo O3 Regional Oximeter System (2022), 1 descendant of its own
- K243324: Masimo O3 Regional Oximeter (2025), 0 descendants of its own
- K162603: Masimo O3 Regional Oximeter System (2017), 0 descendants of its own

## 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 in healthcare environments.

Source page: https://510kreport.com/device/K160526
Methodology: https://510kreport.com/methodology