# K150398: EUM 100Pro

- Pathway: 510(k) (Traditional)
- Applicant: Ob Tools, Ltd.
- Decided: Aug 6, 2015 after 169 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.
No later device cites it as a predicate yet.
0 of 4 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 4.

## Indications for use
The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity and fetal heart rate (FHR). The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen. The EUM100Pro is intended for use on women (>36 completed weeks of gestation) in labor, with singleton pregnancies. The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K150398
Methodology: https://510kreport.com/methodology