# K254036: Novii+ Wireless Patch System

- Pathway: 510(k) (Traditional)
- Applicant: Datex Ohmeda, Inc.
- Decided: Aug 10, 2026 after 237 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894277 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231964: Novii+ Wireless Patch System, Datex Ohmeda (2023) Summary page 5.

## Indications for use
The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires 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 34 weeks and 0/7 days and greater 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 Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent 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/K254036
Methodology: https://510kreport.com/methodology