510(k) Report

Devices descending from K092129

7 later devices reach Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151461Hybernite RTPlastiflex Group NV20162—
+1K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc.20113—
+2K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant…Medline Industries, LP20260—
+2K234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit…Medline Industries, LP20240—
+2K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+3K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+3K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—