510(k) Report

Devices descending from K071958

8 later devices reach Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092256Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Smiths Medical Asd, Inc.20102—
+1K100104Hybernite Rainout Control SystemPlastiflex Group NV20106—
+2K122705Humicare D900Grundler GmbH20131—
+2K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+3K133766Humicare D900Gruendler GmbH20140—
+3K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+4K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+4K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—