# K142883: MindChild Meridian M100 Fetal Heart Rate Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mindchild Medical
- Decided: Apr 17, 2015 after 197 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900480 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120018: Mindchild Meridian Fetal Heart Rate Monitor, Mindchild Medical (2012) Summary page 4.

## Indications for use
The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor. The MindChild Meridian M 100 is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The MindChild Meridian is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K142883
Methodology: https://510kreport.com/methodology