510(k) Report

Devices descending from K100104

6 later devices reach Hybernite Rainout Control System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122705Humicare D900Grundler GmbH20131—
+1K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+2K133766Humicare D900Gruendler GmbH20140—
+2K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+3K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+3K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—