# K181956: Masimo MightySat Rx Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jan 23, 2019 after 184 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: 19 generations back to K962603 (1997). 110 ancestors in all.
23 later devices descend from it; 6 cite it directly.
1 of 134 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141518: Nellcor Bedside Respiratory Patient Monitoring System, Covidien (2015) Summary page 4.
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2015) Summary page 4.

## Most influential descendants
- 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
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own

## Indications for use
The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments, and transport. 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) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of respiration rate (RRp) for adult patients.

Source page: https://510kreport.com/device/K181956
Methodology: https://510kreport.com/methodology