510(k) Report

Devices descending from K110398

3 later devices reach Respironics Disposable Heated Wire Circuits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+2K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+2K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—