# K140862: Monica Novii Wireless Patch System

- Pathway: 510(k) (Traditional)
- Applicant: Monica Healthcare, Ltd.
- Decided: Aug 27, 2014 after 146 days
- Product code: OSP (Uterine Electromyographic Monitor)
- Device class: 2
- Regulation: 21 CFR 884.2720
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894277 (1989). 18 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101801: Monica AN24, Monica Healthcare (2011) Summary page 4.
- K112390: Monica AN24, Monica Healthcare, Ltd. (2012) Summary page 4.
- K112163: Monica IF24, Monica Healthcare (2011) Summary page 4.
- K041026: Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S, Ambu, Inc. (2004) Summary page 4.

## Most influential descendants
- K231964: Novii+ Wireless Patch System (2023), 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

## Recalls of this device
- Dec 15, 2017 · Class II · Z-1292-2018: if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapp
- Apr 28, 2017 · Class II · Z-2588-2017: Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

## Indications for use
The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The Novii Patch is an accessory to the Novii Pod that connects directly to the Novii Pod and contains the surface electrodes that attach to the abdomen. The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The Novii Pod maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting

Source page: https://510kreport.com/device/K140862
Methodology: https://510kreport.com/methodology