# K142583: LaborView LV1000

- Pathway: 510(k) (Traditional)
- Applicant: Obmedical Company
- Decided: Jan 16, 2015 after 123 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 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)
- K112390: Monica AN24, Monica Healthcare, Ltd. (2012) Summary page 4.

## Most influential descendants
- K190798: LaborView™ LV1000 Wireless Electrode System (2020), 0 descendants of its own

## Indications for use
The LaborView LV1000™ Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.

Source page: https://510kreport.com/device/K142583
Methodology: https://510kreport.com/methodology