510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K061736Substantially Equivalent

Comfort Flo Humidification System and Nasal Cannula

Teleflex Medical, Bannockburn IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061736 is the FDA 510(k) clearance record for COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA, a class II device, cleared for Teleflex Medical on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 80 510(k) clearances for Teleflex Medical, from to . As of , FDA records show no recalls naming K061736.

Clearance record

Decision date
Received
(59 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Teleflex Medical 2345 Waukegan Rd., Bannockburn IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to November 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260