QYU · Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Cardiovascular · 21 CFR 870.2705 · Class 2
Overview
| Product Code | QYU |
|---|---|
| Device Name | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use |
| Regulation | 21 CFR 870.2705 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
The Dream Sock is an infant pulse rate and oxygen saturation monitor for over-the-counter (OTC) use. It uses photoplethysmography (PPG) to measure pulse rate (PR) and oxygen saturation (SpO2) in infants 1 to 18 months of age and 6 to 30 lbs. The device analyzes PPG data to identify when PR or SpO2 moves outside a preset range, provides notifications to the caregiver, and displays PR, SpO2, and trend data. It is intended for use in a home environment to supplement caregiver decision-making and is not intended to replace traditional monitoring, diagnosis, or treatment, nor is it for use with infants diagnosed with cardiovascular or respiratory conditions.
Classification Rationale
Class II (special controls). The device is classified as Class II under 21 CFR 870.2705, subject to special controls in addition to general controls to mitigate risks such as poor signal quality, misinterpretation of output, adverse tissue reaction, and false positive/negative results.
Special Controls
In combination with the general controls of the FD&C Act, the infant pulse rate and oxygen saturation monitor for over-the-counter use is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234021 | Masimo Stork | Masimo Corporation | May 3, 2024 | SESE |
| DEN220091 | Dream Sock | Owlet Babycare, Inc. | Nov 8, 2023 | DENG |
Top Applicants
- Masimo Corporation — 1 clearance
- Owlet Babycare, Inc. — 1 clearance
