FDA product code QTG: Infant Supine Sleep System

QTG is the FDA product code for infant supine sleep system. It is a Class II device, regulated under 21 CFR 880.5690 and reviewed by the General Hospital panel. Devices under QTG reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 3 recalls for QTG devices, 3 initiated in the last five years.

Definition

An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).

Classification

Recalls for QTG devices

3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-08-07.

Frequently asked questions

What is FDA product code QTG?

QTG is the FDA product code for infant supine sleep system. It is a Class II device, regulated under 21 CFR 880.5690 and reviewed by the General Hospital panel.

What device class is QTG?

Class II, regulation 21 CFR 880.5690. Typical premarket route: 510(k).

Have QTG devices been recalled?

Yes: 3 product recalls across 2 recall events; the most recent began 2026-08-07.

Next steps

• Run an FDA pathway report with predicate devices for product code QTG
• Run a recall and safety report across every QTG manufacturer
• Watch product code QTG for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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