510(k) Report

Devices descending from K993531

119 later devices reach Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230415Cadwell GuardianCadwell Industries, Inc.20230—
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+7K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+7K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+7K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+7K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+7K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+7K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+8K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K213515WesperO2Wesper, Inc.20220—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302