510(k) Report

Devices descending from K113623

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+1K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+2K161056Telemetry TransmitterEdan Instruments, Inc.201702
+2K160981Patient MonitorEdan Instruments, Inc.201681
+2K152552Patient MonitorEdan Instruments, Inc.201621
+3K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+3K192514Patient MonitorEdan Instruments, Inc.202061
+3K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+4K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+4K202336Patient MonitorEdan Instruments, Inc.202131
+5K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+5K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+6K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—