# K101801: Monica AN24

- Pathway: 510(k) (Traditional)
- Applicant: Monica Healthcare
- Decided: Feb 3, 2011 after 220 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.

## Most influential descendants
- K112163: Monica IF24 (2011), 4 descendants of its own
- K140862: Monica Novii Wireless Patch System (2014), 3 descendants of its own
- K231964: Novii+ Wireless Patch System (2023), 1 descendant of its own
- K120018: Mindchild Meridian Fetal Heart Rate Monitor (2012), 1 descendant of its own
- K254036: Novii+ Wireless Patch System (2026), 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) and uterine activity (UA). 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. 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 abdomen. The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K101801
Methodology: https://510kreport.com/methodology