# K191095: Maxxi Snore Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Jan 16, 2020 after 266 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: 1 generation back to K941759 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941759: Snoring Sensor, Epm Development Systems Corp. (1994) Summary page 4.

## Indications for use
The Maxxi Snore Sensor is a device intended to acquire snore bursts. It responds to snoring and other sounds in the audio range picked up through the skin and convert them to a small analog voltage that provides an indication of the presence of these sound/vibration bursts. This sensor is intended to be used with polysomnography devices and adult patients. Intended to be use in a sleep laboratory, clinics or hospitals.

Source page: https://510kreport.com/device/K191095
Methodology: https://510kreport.com/methodology