510(k) Report

Devices descending from K121955

14 later devices reach Coughassist T70 Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242438ClearoBreas Medical AB20250—
+1K191912BiWaze CoughAbmrc, LLC20200—
+1K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+1K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl20141—
+1K140605Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl20140—
+1K122111Respironics Simplyclear DeviceRespironics, Inc.20124—
+2K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.20260—
+2K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc.20240—
+2K181166Trilogy EvoRespironics, Inc.20195Class I
+3K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+3K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+4K233452Vivo 45 LSBreas Medical AB202501