510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170090Unknown

MATRx plus

Zephyr Sleep Technologies, Calgary, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170090 is the FDA 510(k) clearance record for MATRx plus, a class II device, cleared for Zephyr Sleep Technologies on under FDA product code QCJ (Closed Loop Auto Titration Device For Oral Appliances). FDA's definition for product code QCJ 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...". FDA records list 7 510(k) clearances for Zephyr Sleep Technologies, from to . As of , FDA records show no recalls naming DEN170090.

Clearance record

Decision date
Received
(245 days to decision)
Product code
QCJ Closed Loop Auto Titration Device For Oral Appliances
Regulation
21 CFR 872.5571
Device class
Class II
Review panel
Dental
Applicant
Zephyr Sleep Technologies 610a 70 Ave. SE, Calgary, CA
Third party review
No

Clearances, product code QCJ

Trailing 12 months

FDA records hold no clearances under product code QCJ in the trailing twelve months.

FDA records show no clearances under product code QCJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260