# K181996: MATRx Plus

- Pathway: 510(k) (Traditional)
- Applicant: Zephyr Sleep Technologies
- Decided: Nov 21, 2018 after 118 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: 11 generations back to K913396 (1992). 44 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163665: MATRx plus, Zephyr Sleep Technologies (2017) Summary page 4.

## Most influential descendants
- K191925: MATRx Plus (2019), 1 descendant of its own
- K200695: MATRx plus (2020), 0 descendants of its own

## Indications for use
The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients. MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.

Source page: https://510kreport.com/device/K181996
Methodology: https://510kreport.com/methodology