# K112390: Monica AN24

- Pathway: 510(k) (Traditional)
- Applicant: Monica Healthcare, Ltd.
- Decided: Jul 13, 2012 after 330 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 K900480 (1990). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954351: Series 50XM, Hewlett-Packard GmbH (1996) Summary page 1.
- (no number) Philips M1191A: named in the summary without a submission number

## Most influential descendants
- K140862: Monica Novii Wireless Patch System (2014), 3 descendants of its own
- K231964: Novii+ Wireless Patch System (2023), 1 descendant of its own
- K142583: LaborView LV1000 (2015), 1 descendant of its own
- K254036: Novii+ Wireless Patch System (2026), 0 descendants of its own
- K233440: Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (2024), 0 descendants of its own

## Indications for use
The Monica AN24 is an intrapartumn maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate(MHR). The AN24 acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal EGG (fECG) signal. Using the same surface electrodes, the AN24 also acquires and displays the UA tracing from the uterine electromyography.(EMG) signal and the MHR tracing from the-maternal EGG signal (mECG). The AN24 is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdolmen. The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting. The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K112390
Methodology: https://510kreport.com/methodology