# K161902: Meridian M110 Fetal Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Mindchild Medical
- Decided: Jan 12, 2017 after 185 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor. The Meridian M110 Fetal Monitoring System is indicated for use on women who are at > 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The Meridian M 110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.

Source page: https://510kreport.com/device/K161902
Methodology: https://510kreport.com/methodology