510(k) Report

Devices descending from K012487

21 later devices reach Sphygmocor PX Model Scor-PX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121266CardioscopePulsecor Limited20120—
+1K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd.20102—
+1K081654HEM-9000AIOmron Healthcare, Inc.20080—
+1K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd.20074—
+1K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.200716—
+1K050233Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AIOmron Healthcare, Inc.20056—
+2K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+2K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+2K122129Sphygmocor XcelAtcor Medical20126—
+2K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH20118—
+2K092809HRV AcquireWr Medical Electronics Co.20100—
+2K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+3K221742Conneqt PulseAtcor Medical20230—
+3K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+3K151520Oscar 2Suntech Medical, Inc.201632
+3K140928ABPM7100I.E.M. GmbH20145—
+3K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+4K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+4K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+4K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH20160—
+5K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—