# K120018: Mindchild Meridian Fetal Heart Rate Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mindchild Medical
- Decided: Sep 19, 2012 after 260 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: 3 generations back to K900480 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101801: Monica AN24, Monica Healthcare (2011) Summary page 1.
- K900480: M1350A Fetal Monitor (Intrapartum), Hewlett-Packard Co. (1990) Summary page 1.

## Most influential descendants
- K142883: MindChild Meridian M100 Fetal Heart Rate Monitor (2015), 0 descendants of its own

## Indications for use
The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian is indicated for use on women who are at term (> 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/K120018
Methodology: https://510kreport.com/methodology