510(k) Report

Devices descending from K010463

38 later devices reach Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+1K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055—
+1K011670Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion…Datex-Ohmeda2001301
+2K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+2K031781Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and AccessoriesDatex-Ohmeda20030—
+2K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…Datex-Ohmeda, Inc.200228Class I
+3K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+3K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+3K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc.200427Class I
+4K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+4K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+4K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+4K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy20130—
+4K073203Carescape V100Ge Medical Systems Information Technologies200720—
+4K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda20050—
+4K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+5K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+5K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+5K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+6K152659V10Mediana Co., Ltd.20162—
+6K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+6K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K170497V10Mediana Co., Ltd.201711
+7K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+7K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+8K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+8K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+8K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+8K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+9K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+9K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741