# DEN170090: MATRx plus

- Pathway: De Novo (Direct)
- Applicant: Zephyr Sleep Technologies
- Decided: Aug 23, 2018 after 245 days
- Product code: QCJ (Closed Loop Auto Titration Device For Oral Appliances)
- Device class: 2
- Regulation: 21 CFR 872.5571
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## 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 MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position. The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.

Source page: https://510kreport.com/device/DEN170090
Methodology: https://510kreport.com/methodology