510(k) Report

Devices descending from K002768

15 later devices reach Acapella through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181660Acapella Choice Blue Vibratory PEP DeviceSmiths Medical20190—
+1K160636iPEP System and vPEPD R Burton Healthcare, LLC20160—
+1K140772Aerosure MedicActegy, Ltd.20141—
+1K133057Vibralung Acoustical PercussorWestmed, Inc.20140—
+1K132988Vital CoughLung Assist, Inc.20145—
+1K123400Aerobika Positive Expiratory Pressure DeviceTrudell Medical Intl.20132—
+1K092560Pari SinusPari Respiratory Equipment, Inc.20100—
+2K203378PulsehalerRespinova, Ltd.20210—
+2K192143Maximus SystemHill-Rom Services Pte, Ltd.20204Class I
+2K150173Aerobika OPEP Devive with ManometerTrudell Medical International20151—
+3K200988Maximus SystemHill-Rom Services Pte, Ltd.20203Class I
+3K183108Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International20190—
+4K231728BiWaze Clear SystemAbmrc, LLC20241—
+4K213564BiWaze Clear SystemAbmrc, LLC20220—
+5K260604BiWaze Clear SystemAbmrc, LLC20260—