# K191401: PregSense

- Pathway: 510(k) (Traditional)
- Applicant: Nuvo- Group, Ltd.
- Decided: Mar 27, 2020 after 308 days
- Product code: LQK (Home Uterine Activity Monitor)
- Device class: 2
- Regulation: 21 CFR 884.2730
- 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 K002548 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143114: Sense4Baby System Model B+ (MSA), Airstrip Technologies, Inc. (2015) Summary page 4.

## Indications for use
PregSense is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR). The PregSense acquires and displays the FHR and MHR tracings from abdominal surface electrodes that pick up the fetal heart biopotential and maternal heart biopotential signal, and from surface acoustic sensors that pick up the fetal PCG (fPCG; phonocardiogram) and the maternal PCG (mPCG; phonocardiogram) signals. PregSense is indicated for use by pregnant women who need documentation of fetal heart rate activity, and who are in their 32nd week of gestation (or later), with a singleton pregnancy. PregSense is intended to be used for a maximum of five minutes. The PregSense maternal-fetal monitor is intended for use in the antepartum period by healthcare professionals in health care facilities and by the patient in the patient’s home, on the order of a physician. The PregSense is not intended for use in critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor. PregSense is not intended to be used for antepartum monitoring (e.g., non-stress testing).

Source page: https://510kreport.com/device/K191401
Methodology: https://510kreport.com/methodology