510(k) Report

Devices descending from K012059

15 later devices reach 8100/8500 Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161420Moves SLCThornhill Research, Inc.20170—
+1K101602Vital Signs MonitorCriticare Systems, Inc.20100—
+1K093261MOVESThornhill Research, Inc.20107Class I
+1K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+1K0425698600 Vital Signs MonitorCriticare Systems, Inc.200403
+1K030613Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc.200311
+2K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+2K140049Moves SLCThornhill Research, Inc.20141—
+2K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+3K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+3K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+4K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—