# K160940: Masimo Disposable Transflectance Forehead Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Nov 23, 2016 after 233 days
- Product code: DQA (Oximeter)
- 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: 7 generations back to K962603 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032551: Masimo Lnop-TF-I Resuable Transflectance Sensor, Masimo Corp. (2004) Summary page 4.

## Indications for use
The Masimo Disposable Transflectance Forehead Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Masimo Disposable Transflectance Forehead Sensors are intended for use with adult and pediatric patients, weighing greater than 10 kg, who are well or poorly perfused in healthcare environments.

Source page: https://510kreport.com/device/K160940
Methodology: https://510kreport.com/methodology