510(k) Report

Devices descending from K040073

31 later devices reach Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071967Sysmex XE-5000Sysmex America, Inc.2007291
+1K050235IQ 200 Urine Analyzer Body Fluids ModuleIris International, Inc.20052—
+2K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.202116
+2K181288Athelas OneAthelas, Inc.20182—
+2K141681Sysmex XN SeriesSysmex America, Inc.201401
+2K112605Sysmex XN-SeriesSysmex America, Inc.2012202
+2K091313Sysmex Model XT-4000ISysmex America, Inc.20103—
+3K243348Athelas HomeAthelas, Inc.20260—
+3K252580iQ200 SeriesBeckman Coulter, Inc.202502
+3K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.20251—
+3K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.20251—
+3K240402Cito CBC SystemCytochip, Inc.20250—
+3K232946Yumizen H2500Horiba Abx Sas20241—
+3K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerSysmex America, Inc.20230—
+3K220031Alinity h-series SystemAbbott Laboratories202312
+3K200828Athelas HomeAthelas, Inc.20221—
+3K190898Sight OLOSight Diagnostics, Ltd.201924
+3K182389Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc.20190—
+3K180020HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.20182—
+3K171655cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc.201801
+3K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CTHoriba Abx Sas20170—
+3K160538Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc.20160—
+3K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.201601
+3K091539IQ 200 Urine Analizer Body Fluids ModuleIris Diagnostics20102—
+4K260781Yumizen H550Horiba Abx Sas20260—
+4K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.20260—
+4K251249Tru Hematology TestTruvian Sciences, Inc.20260—
+4K243283Alinity h-series SystemAbbott Laboratories202501
+4K222148HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.20231—
+4K211840Sight OLOS.D. Sight Diagnostics, Ltd.202201
+5K240636HemoScreen Hematology AnalyzerPixcell Medical Technologies20240—