Therapeutic devices · 21 CFR 872 Subpart F

Closed Loop Auto Titration Device for Oral Appliances

A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patients respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then 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.

FDA codeQCJClass221 CFR872.5571Pathway510(k)

Companies listing it: 00 makers
Brands and models: 0
510(k) clearances: 10 in five years
FDA name: Closed Loop Auto Titration Device For Oral Appliances

510(k) clearances per year, 1976–2026

510(k) clearances

Decided	510(k)	Device	Applicant
23 Aug 2018	DEN170090	MATRx plus	Zephyr Sleep Technologies, Inc.

Official records: FDA product classification for QCJ · 21 CFR 872.5571.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026