510(k) Report

Devices descending from K993757

116 later devices reach SOLAR 7/8000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+7K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+8K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy20260—
+8K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K213515WesperO2Wesper, Inc.20220—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+11K253034HemoSphere Stream ModuleEdwards Lifesciences20250—