510(k) Report

Devices descending from K063690

28 later devices reach Colin Press Mate, Model BP S510 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112190Patient MonitorMediana Co., Ltd.20110—
+1K082812Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc.200827—
+2K112478Visi Mobile Monitoring SystemSotera Wireless, Inc.2012242
+2K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+3K142087Cova Monitoring SystemTosense, Inc.20151—
+3K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+3K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K160899CoVa Monitoring System 2Tosense, Inc.20170—
+4K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+4K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+4K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+5K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K223721Masimo StorkMasimo Corporation20230—