# K214115: MightySat -OTC

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Jan 31, 2024 after 762 days
- Product code: OLK (Pulse Oximeter For Over-The-Counter Use)
- 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: 20 generations back to K962603 (1997). 111 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 113 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2019) Summary page 4.

## Most influential descendants
- K211498: Nonin OTC Pulse Oximeter Model 3250 (2024), 0 descendants of its own

## Indications for use
The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions. The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

Source page: https://510kreport.com/device/K214115
Methodology: https://510kreport.com/methodology