# K232111: NeoBeat, NeoBeat Mini

- Pathway: 510(k) (Traditional)
- Applicant: Laerdal Medical AS
- Decided: Jun 25, 2024 after 347 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K941811 (1994). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131762: Handheld Monitor, Guangdong Biolight Meditech Co., Ltd. (2014) Summary page 5.

## Indications for use
NeoBeat and NeoBeat Mini are indicated to continuously measure and display the heart rate of neonates using dry electrodes on the torso during transition, stabilization and/or resuscitation. The devices are intended to be used in healthcare facilities. NeoBeat is intended for use on newborns approximately 1.5-5 kg. NeoBeat Mini is intended for newborns approximately 0.5-2 kg.

Source page: https://510kreport.com/device/K232111
Methodology: https://510kreport.com/methodology