510(k) Report

Devices descending from K082660

14 later devices reach V60 Ventilator, Model V8000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+1K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+1K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+2K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+2K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+2K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+2K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+3K242931HFT750UMekics Co., Ltd.20250—
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+5K233452Vivo 45 LSBreas Medical AB202501