510(k) Report

Devices descending from K010402

3 later devices reach Smooth-Flo Circuit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061736Comfort Flo Humidification System and Nasal CannulaTeleflex Medical20062—
+2K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Teleflex, Inc.20141Class I
+3K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.20170Class I