# DEN200042: BrainTemp Neonate System (BTNeo System)

- Pathway: De Novo (Direct)
- Applicant: Brain Temp, Inc.
- Decided: Mar 29, 2022 after 644 days
- Product code: QSL (Brain Temperature Measurement System)
- Device class: 2
- Regulation: 21 CFR 882.1565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The BTNeo System is indicated for measurement of a neonate’s brain temperature. The brain temperature may be displayed with a compatible vital sign monitor system and is intended to be displayed along with core temperature. The BTNeo System is indicated for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms.

Source page: https://510kreport.com/device/DEN200042
Methodology: https://510kreport.com/methodology