QCJClass II

Closed Loop Auto Titration Device For Oral Appliances

21 CFR 872.5571 / Dental

QCJ is the FDA product code for Closed Loop Auto Titration Device For Oral Appliances, a class II device type, regulated under 21 CFR 872.5571. FDA's definition for this code reads: "A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s 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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2018-08-23, and no recalls.

Classification record

Product code: QCJ
Device name: Closed Loop Auto Titration Device For Oral Appliances
FDA definition: A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s 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.
Regulation: 21 CFR 872.5571
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QCJ

By decision year

1 clearance under product code QCJ with a decision year between 2018 and 2018, 2018 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QCJ by decision year
Year	Clearances
2018	1

Applicants with the most clearances

Product code QCJ

Applicants holding the most 510(k) clearances under product code QCJ
Applicant	Clearances
Zephyr Sleep Technologies	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QCJ.

Recent clearances

Product code QCJ

DEN170090Class IIMATRx plusZephyr Sleep Technologies / cleared 2018-08-23

Recent recalls

Product code QCJ

FDA records show no recalls under product code QCJ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-06. View this product code on fda.gov (opens on fda.gov)