510(k) Report

Devices descending from K122111

4 later devices reach Respironics Simplyclear Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc.20240—
+1K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl20141—
+1K140605Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl20140—
+2K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.20260—