510(k) Report

Devices descending from K991300

11 later devices reach Boeing, Positive Airway Pressure (Pap) Therapy Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192000D R Burton OxyPAPD R Burton Healthcare, LLC20200—
+1K173918VersaPAP Positive Airway Pressure (PAP) DeviceTrudell Medical International20181—
+1K051964PowernebComedica, Inc.20057—
+2K183108Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International20190—
+2K151689MetaNeb 4 SystemHill-Rom Services Pte, Ltd.20165—
+2K124032MetanebHill-Rom Services Pte, Ltd.20136—
+3K192143Maximus SystemHill-Rom Services Pte, Ltd.20204Class I
+4K200988Maximus SystemHill-Rom Services Pte, Ltd.20203Class I
+5K231728BiWaze Clear SystemAbmrc, LLC20241—
+5K213564BiWaze Clear SystemAbmrc, LLC20220—
+6K260604BiWaze Clear SystemAbmrc, LLC20260—