510(k) Report

Devices descending from K071967

29 later devices reach Sysmex XE-5000 through their predicates, nearest generation first.

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