510(k) Report

Devices descending from K940986

13 later devices reach Flutter (R) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp.19995—
+1K972859Flutter DBradstreet Clinical Research Assoc., Inc.19989—
+2K233855AllPEPEnchant Tek Co., Ltd.20240—
+2K203209AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd.20211—
+2K160636iPEP System and vPEPD R Burton Healthcare, LLC20160—
+2K150044O-PEPPari Respiratory Equipment, Inc.20160—
+2K140772Aerosure MedicActegy, Ltd.20141—
+2K133057Vibralung Acoustical PercussorWestmed, Inc.20140—
+2K063645Frequencer, Model 1001Dymedso, Inc.20073—
+3K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc.20240—
+3K203378PulsehalerRespinova, Ltd.20210—
+3K100749Frequencer Model V2XDymedso, Inc.20102—
+4K103176FrequencerDymedso, Inc.20111—