# K201495: Maxxi Flow Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Dec 14, 2020 after 192 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 K922112 (1992). 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)
- K922112: Easyflow, Epm Information Systems, Inc. (1992) Summary page 4.

## Indications for use
The Maxxi Flow sensor is a respiratory sensor. It is placed under the patient’s nostrils and produce a signal that is directly proportional to the temperature changes of air inhaled and exhaled during respiration. Maxxi Flow sensors generate a small analog electrical signal that provides a clear, reliable indication of respiration airflow. 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/K201495
Methodology: https://510kreport.com/methodology