510(k) Report

Devices descending from K990966

477 later devices reach Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+9K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+9K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+9K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+9K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+9K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+9K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+9K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+9K103211Avea VentilatorCare Fusion20115Class I
+10K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+10K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+10K260880SedLine Sedation MonitorMasimo Corporation20260—
+10K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+10K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+10K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+10K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+10K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K241397HinscopeHinlab Sas20240—
+10K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+10K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+10K222550Current Health SystemCurrent Health, Ltd.20221—
+10K210384Carescape R860Datex-Ohmeda, Inc.20210—
+10K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+10K193228Hamilton-G5Hamilton Medical AG20201—
+10K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+10K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+10K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+10K170872Aisys CS2Datex-Ohmeda, Inc.201704
+10K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+10K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+10K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+10K122438Hamilton-MR1Hamilton Medical AG201311
+10K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+11K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+11K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+11K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+11K231506Current Health SystemCurrent Health, Ltd.20230—
+11K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+11K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+11K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+11K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+11K191882Masimo Centroid SystemMasimo Corporation20203—
+11K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+11K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+11K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+11K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+11K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+11K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+12K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+12K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+12K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+12K240251ANNE ChestSibel Health, Inc.20240—
+12K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+12K223498Radius VSM and AccessoriesMasimo Corporation202312
+12K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+12K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+12K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+12K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+12K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+12K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+12K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+12K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+12K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+13K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K250757Radius VSM and AccessoriesMasimo Corporation20250—
+13K231531Pediarity™Hinlab, Inc.20230—
+13K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—