510(k) Report

Devices descending from K160981

8 later devices reach Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+1K192514Patient MonitorEdan Instruments, Inc.202061
+2K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+2K202336Patient MonitorEdan Instruments, Inc.202131
+3K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+3K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+4K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+4K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—