510(k) Report

Devices descending from K002598

24 later devices reach Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl20141—
+1K140605Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl20140—
+1K113549Comfort CoughSeoil Pacific Corp.20130—
+1K122111Respironics Simplyclear DeviceRespironics, Inc.20124—
+1K121955Coughassist T70 DeviceRespironics, Inc.201214—
+1K120277Vital CoughLung Assist, Inc.20126—
+1K072292Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl200816—
+2K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.20260—
+2K242438ClearoBreas Medical AB20250—
+2K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc.20240—
+2K191912BiWaze CoughAbmrc, LLC20200—
+2K192143Maximus SystemHill-Rom Services Pte, Ltd.20204Class I
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+2K132988Vital CoughLung Assist, Inc.20145—
+3K200988Maximus SystemHill-Rom Services Pte, Ltd.20203Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K231728BiWaze Clear SystemAbmrc, LLC20241—
+4K213564BiWaze Clear SystemAbmrc, LLC20220—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+5K260604BiWaze Clear SystemAbmrc, LLC20260—
+5K233452Vivo 45 LSBreas Medical AB202501