# K171304: Maxxi Rip Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Jun 24, 2019 after 782 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K910772 (1991). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151361: Nox RIP Belts & Cables, Nox Medical Ehf (2015) Summary page 4.

## Indications for use
Maxxi RIP Sensor is intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. The device is offered in different sizes to be used on adult patients. The intended environments are hospitals, institutions, sleep centers or sleep clinics.

Source page: https://510kreport.com/device/K171304
Methodology: https://510kreport.com/methodology
