Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5690](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5690) → QTG — Infant Supine Sleep System

# QTG · Infant Supine Sleep System

_General Hospital · 21 CFR 880.5690 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QTG

## Overview

- **Product Code:** QTG
- **Device Name:** Infant Supine Sleep System
- **Regulation:** [21 CFR 880.5690](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5690)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

The SNOO Smart Sleeper is an infant supine sleep system comprised of a bassinet and a sleep sack that jointly constitute an infant securement device intended to facilitate a supine position during sleep. It is intended for home use by caregivers of infants from birth to 6 months of age who are not yet able to roll over consistently.

## Classification Rationale

Class II (special controls). The device is subject to the general controls of the FD&C Act and the identified special controls.

## Special Controls

In combination with the general controls of the FD&C Act, the infant supine sleep system is subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN210039](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QTG/DEN210039.md) | SNOO Smart Sleeper | Happiest Baby, Inc. | Mar 30, 2023 | DENG |

## Top Applicants

- Happiest Baby, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QTG](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QTG)

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