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Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Sysmex Corp. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
344 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012372SYSMEX UF-50Sysmex Corp.2001-09-28640
K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERSysmex Corp.1999-11-09751
K981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-350Sysmex Corp.1998-11-031530
K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERSysmex Corp.1998-08-14870
K971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERSysmex Corp.1997-08-261060
K964946SYSMEX CA-1000/SYSMEX CA-5000Sysmex Corp.1997-03-18980
K964375SYSMEX SE/RAM-1Sysmex Corp.1997-03-131320
K961054SYSMEX UF-100Sysmex Corp.1996-10-282240
K950508SYSMEX SF-3000Sysmex Corp.1995-11-032700
K945837SYSMEX(TM) F-820, 520Sysmex Corp.1995-06-091920
K942096TOA MEDICAL ELECTRONICS CA-1000Sysmex Corp.1995-03-243440
K942097TOA MEDICAL ELECTRONICS CA-5000Sysmex Corp.1995-03-243440
K943894SYSMEX K-4500Sysmex Corp.1995-02-031780
K790029FLUID, RHEMOX W LYSINGSysmex Corp.1979-02-26540
K790028DILUENT, CELLENT BLOODSysmex Corp.1979-02-15430
K790030FLUID, RHEMOX-HB LYSINGSysmex Corp.1979-02-08360
K790026ANALYZER, MODEL CC-720Sysmex Corp.1979-02-08360
K790027SHAKER, MODEL SH-510Sysmex Corp.1979-02-08360

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda