# K150314: Masimo MightySat Rx Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Oct 22, 2015 after 255 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: 18 generations back to K962603 (1997). 87 ancestors in all.
24 later devices descend from it; 1 cites it directly.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081285: Finger Pulse Oximeter, Model 9560, Nonin Medical, Inc. (2008) Summary page 4.
- K142394: Masimo Root Monitoring System and Accesories, Masimo Corporation (2014) Summary page 4.

## Most influential descendants
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own
- K181352: Loop System (2019), 10 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own

## Indications for use
The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR). The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

Source page: https://510kreport.com/device/K150314
Methodology: https://510kreport.com/methodology