Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sysmex America, Inc. — Predicate Candidate Screening

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

100 daysmedian FDA review time

304 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253212	XR-Series (XR-10, XR-20) Automated Hematology Analyzers	Sysmex America, Inc.	2026-05-27	240	0
K250943	Sysmex XR-Series (XR-10) Automated Hematology Analyzer	Sysmex America, Inc.	2025-06-25	89	0
K251371	Sysmex XR-Series (XR-20) Automated Hematology Analyzer	Sysmex America, Inc.	2025-06-25	54	0
K250965	Automated Blood Coagulation Analyzer CN-Series (CN-6000)	Sysmex America, Inc.	2025-06-02	63	0
K230887	Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer	Sysmex America, Inc.	2023-12-21	265	0
K210346	Sysmex XW-100 Automated Hematology Analyzer	Sysmex America, Inc.	2022-11-08	638	0
K182389	Sysmex XN-L Automated Hematology Analyzer	Sysmex America, Inc.	2019-01-25	143	0
K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging	Sysmex America, Inc.	2018-10-30	90	0
K171883	Sysmex UF-5000 Fully Automated Urine Particle Analyzer	Sysmex America, Inc.	2018-04-23	304	0
K172604	XW-100 Automated Hematology Analyzer for CLIA Waived Use	Sysmex America, Inc.	2017-11-06	68	0
K160538	Sysmex XN-L Automated Hematology Analyzer	Sysmex America, Inc.	2016-12-22	300	0
K160541	Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit	Sysmex America, Inc.	2016-10-21	238	0
K143577	XW-100 Automated Hematology Analyzer, XW QC CHECK	Sysmex America, Inc.	2015-10-12	299	0
K141681	SYSMEX XN SERIES	Sysmex America, Inc.	2014-12-05	165	1
K112605	SYSMEX XN-SERIES	Sysmex America, Inc.	2012-10-19	408	2
K091313	SYSMEX MODEL XT-4000I	Sysmex America, Inc.	2010-03-30	330	0
K083002	SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER	Sysmex America, Inc.	2009-02-03	118	0
K081890	SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAME	Sysmex America, Inc.	2008-10-10	100	0
K081610	SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER	Sysmex America, Inc.	2008-08-29	81	0
K080887	SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URIN	Sysmex America, Inc.	2008-05-02	32	1
K071967	SYSMEX XE-5000	Sysmex America, Inc.	2007-11-20	127	1
K070910	SYSMEX MODEL UF1000I	Sysmex America, Inc.	2007-05-25	53	0
K061150	SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES	Sysmex America, Inc.	2006-07-06	72	0
K060656	SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES	Sysmex America, Inc.	2006-05-10	58	0
K053135	SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER	Sysmex America, Inc.	2006-01-04	57	0
K051459	SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER	Sysmex America, Inc.	2005-09-23	113	0
K051199	IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MOD	Sysmex America, Inc.	2005-08-08	90	0
K050589	RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMAT	Sysmex America, Inc.	2005-05-04	57	0
K040073	SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-210	Sysmex America, Inc.	2004-03-18	64	0
K032677	SYSMEX POCH-100I	Sysmex America, Inc.	2004-02-11	166	1
K032039	IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2	Sysmex America, Inc.	2003-09-08	69	0

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