# K131889: Eum 100PRO

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Apr 23, 2014 after 302 days
- Product code: OSP (Uterine Electromyographic Monitor)
- Device class: 2
- Regulation: 21 CFR 884.2720
- 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 K950420 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090145: Surecall Emg Labor Monitor, Reproductive Research Technologies, LP (2011) Summary page 1.
- K112390: Monica AN24, Monica Healthcare, Ltd. (2012) Summary page 4.

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

Source page: https://510kreport.com/device/K131889
Methodology: https://510kreport.com/methodology