510(k) Report

Devices descending from K112605

20 later devices reach Sysmex XN-Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.20251—
+1K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.20251—
+1K240402Cito CBC SystemCytochip, Inc.20250—
+1K232946Yumizen H2500Horiba Abx Sas20241—
+1K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerSysmex America, Inc.20230—
+1K220031Alinity h-series SystemAbbott Laboratories202312
+1K190898Sight OLOSight Diagnostics, Ltd.201924
+1K182389Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc.20190—
+1K180020HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.20182—
+1K171655cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc.201801
+1K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CTHoriba Abx Sas20170—
+1K160538Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc.20160—
+1K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.201601
+2K260781Yumizen H550Horiba Abx Sas20260—
+2K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.20260—
+2K251249Tru Hematology TestTruvian Sciences, Inc.20260—
+2K243283Alinity h-series SystemAbbott Laboratories202501
+2K222148HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.20231—
+2K211840Sight OLOS.D. Sight Diagnostics, Ltd.202201
+3K240636HemoScreen Hematology AnalyzerPixcell Medical Technologies20240—