# K090145: Surecall Emg Labor Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Reproductive Research Technologies, LP
- Decided: Jan 25, 2011 after 734 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: 2 generations back to K950420 (1995). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013477: Toco Lite, Model TD-01, Ventrex, Inc. (2002) Summary page 1.
- K983395: Fetalgard 3000 Fetal Monitor, Analogic Corp. (1999) Summary page 1.

## Most influential descendants
- K131889: Eum 100PRO (2014), 0 descendants of its own
- K130002: Surecall Labor Monitor (2013), 0 descendants of its own

## Indications for use
The SureCALL® EMG Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure intrapartum uterine activity. It is intended for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K090145
Methodology: https://510kreport.com/methodology