# K201770: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Sep 24, 2020 after 87 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K962603 (1997). 95 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193242: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories, Masimo Corporation (2020) Summary page 4.

## Most influential descendants
- K231531: Pediarity™ (2023), 0 descendants of its own

## Recalls of this device
- Feb 15, 2024 · Class II · Z-1538-2024: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- Feb 15, 2024 · Class II · Z-1537-2024: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

## Indications for use
The Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments. The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

Source page: https://510kreport.com/device/K201770
Methodology: https://510kreport.com/methodology