# K221046: Invu by Nuvo

- Pathway: 510(k) (Special)
- Applicant: Nuvo- Group, Ltd.
- Decided: May 6, 2022 after 28 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: 4 generations back to K002548 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210025: INVU by Nuvo, Nuvo- Group, Ltd. (2021) Summary page 4.

## Indications for use
INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA). The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented. INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy. The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient’s home, on the order of a physician. The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing). This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

Source page: https://510kreport.com/device/K221046
Methodology: https://510kreport.com/methodology