# DEN220091: Dream Sock

- Pathway: De Novo (Direct)
- Applicant: Owlet Babycare, Inc.
- Decided: Nov 8, 2023 after 329 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K234021: Masimo Stork (2024), 0 descendants of its own

## Indications for use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment. The Dream Sock is not intended for use with infants previously diagnosed with cardiovascular or respiratory disease or conditions.

Source page: https://510kreport.com/device/DEN220091
Methodology: https://510kreport.com/methodology