# K214072: Masimo O3 Regional Oximeter System

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: May 6, 2022 after 130 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: 16 generations back to K931154 (1993). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201432: Masimo O3 Regional Oximeter System, Masimo Corporation (2020) Summary page 4.

## Most influential descendants
- K243324: Masimo O3 Regional Oximeter (2025), 0 descendants of its own

## Indications for use
The non-invasive Masimo 03 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rS02) in the tissue under the sensors in patients in healthcare environments. The 03@ Regional Oximeter is only to be used with Masimo 03 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results. When used with the 03 Adult Sensor, the 03 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rS02) in adults 40kg. When used with the 03 Pediatric Sensor, the 030 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rS02) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ? 5 kg and < 40 kg. When used with the 03 Neonatal Sensor, the 03 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg. The AcHb, AO2Hb, AHHb provided as part of the Masimo 03 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (AO2Hlb), deoxygenated hemoglobin (AHHb), and total hemoglobin (AcHb) as measured from the Masimo 03 sensor when applied to the cerebral tissue in adults.

Source page: https://510kreport.com/device/K214072
Methodology: https://510kreport.com/methodology