# K234021: Masimo Stork

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: May 3, 2024 after 135 days
- Product code: QYU (Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN220091 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220091: Dream Sock, Owlet Babycare, Inc. (2023) Summary page 4.

## Indications for use
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) during no-motion, motion, and low perfusion conditions of infants and neonates who are 0 to 18 months of age and between 6 to 30 lbs. The Masimo Stork™ is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months and between 6 to 30 lbs. Masimo Stork™ is indicated for use in home environments. The Masimo Stork can be used to supplement a caregiver's decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2; rather, the Masimo Stork™ is intended to provide a notification only when sufficient data are available for analysis. The Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. The Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.

Source page: https://510kreport.com/device/K234021
Methodology: https://510kreport.com/methodology