FDA De Novo · Owlet
DEN220091: Dream Sock (Owlet Babycare, Inc.)
Owlet Babycare, Inc. received FDA De Novo DEN220091 for Dream Sock, with a decision date of Nov 8, 2023.
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | DEN220091 |
|---|---|
| Pathway | De Novo |
| Applicant | Owlet Babycare, Inc. |
| Device name | Dream Sock |
| Product code | QYU: Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2705 |
| Device class | Class 2 |
| Date received | Dec 14, 2022 |
| Decision date | Nov 8, 2023 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Dream Sock is indicated as follows: 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 | 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 feature 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 feature 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.
Extracted automatically from FDA's decision summary with OCR. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 1 record in this database cites DEN220091 as a predicate (listed below).
Later records that cite DEN220091
- K234021 Masimo Stork (Masimo, May 3, 2024, QYU)
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2705). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QYU is "Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use", class 2, 21 CFR 870.2705. FDA's definition: "An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s)."
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Other. These are heuristics, not FDA fields.