510(k) Report

Devices descending from K052597

7 later devices reach Breathex Omega Cpap Device, Model 322 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121374ZI BlowerDeshum Medical20131—
+1K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+1K071069Mini Cpap Device and Humidifier AccessoryViasys Sleep Systems, LLC20070—
+2K150365Cloud9 SystemInsleep Technologies, LLC20150—
+2K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+2K132127Transcend AutoSomnetics International, Inc.20131—
+3K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—