510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170044Unknown

ClearMate

Thornhill Research Inc, Toronto, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170044 is the FDA 510(k) clearance record for ClearMate, a class II device, cleared for Thornhill Research, Inc. on under FDA product code QFB (Isocapnic Ventilation Device). FDA's definition for product code QFB reads: "An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir...". FDA records list 5 510(k) clearances for Thornhill Research, Inc., from to . As of , FDA records show no recalls naming DEN170044.

Clearance record

Decision date
Received
(573 days to decision)
Product code
QFB Isocapnic Ventilation Device
Regulation
21 CFR 868.5480
Device class
Class II
Review panel
General Hospital
Applicant
Thornhill Research, Inc. 210 Dundas St. W., Toronto, CA
Third party review
No

Clearances, product code QFB

Trailing 12 months

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

FDA records show no clearances under product code QFB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFB, 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