510(k) Report

Devices descending from K021154

12 later devices reach Goldway Patient Monitor, Model # UT4000F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+1K101052Omni Iii Patient MonitorInfinium Medical20106—
+1K082008Bionet BM3PLUS Patient MonitorBionet Co., Ltd.20081—
+1K033988Goldway UT4000A Vital Signs MonitorGoldway (Us), Inc.20042—
+2K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+2K132229Omni Patent MonitorsInfinium Medical20142—
+2K132033BM3/BM3 PlusNoblitt & Rueland20130—
+2K103268Omni ExpressInfinium Medical20105—
+3K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+3K142244Cleo Patient MonitorInfinium Medical201501
+3K103737Omni II Patient MonitorInfinium Medical20114—
+4K112329Omni Patient MonitorInfinium Medical20113—