# K223721: Masimo Stork

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Dec 15, 2023 after 368 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: 14 generations back to K962603 (1997). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2022) Summary page 5.

## Indications for use
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments. The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, motion, and low perfusion conditions. The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

Source page: https://510kreport.com/device/K223721
Methodology: https://510kreport.com/methodology