510(k) Report

Devices descending from K962749

19 later devices reach Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222018Breathe+Peep Medical, LLC Dba Go2 Devices20230—
+1K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp.19995—
+1K991300Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp.199911—
+2K233855AllPEPEnchant Tek Co., Ltd.20240—
+2K192000D R Burton OxyPAPD R Burton Healthcare, LLC20200—
+2K173918VersaPAP Positive Airway Pressure (PAP) DeviceTrudell Medical International20181—
+2K160636iPEP System and vPEPD R Burton Healthcare, LLC20160—
+2K140772Aerosure MedicActegy, Ltd.20141—
+2K133057Vibralung Acoustical PercussorWestmed, Inc.20140—
+2K051964PowernebComedica, Inc.20057—
+3K203378PulsehalerRespinova, Ltd.20210—
+3K183108Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International20190—
+3K151689MetaNeb 4 SystemHill-Rom Services Pte, Ltd.20165—
+3K124032MetanebHill-Rom Services Pte, Ltd.20136—
+4K192143Maximus SystemHill-Rom Services Pte, Ltd.20204Class I
+5K200988Maximus SystemHill-Rom Services Pte, Ltd.20203Class I
+6K231728BiWaze Clear SystemAbmrc, LLC20241—
+6K213564BiWaze Clear SystemAbmrc, LLC20220—
+7K260604BiWaze Clear SystemAbmrc, LLC20260—