# Sysmex America, Inc.

- Location (FDA's records): Mundelein, IL
- FDA decisions: 31 (2003–2026): 31 510(k) clearances
- Product codes: GKZ (22), LKM (5), JLW (1), JPA (1), GKL (1), JOY (1)
- 510(k) review time since 2016: median 191 days, against 224 for FDA's reviews in the same codes and years (6 of 10 faster)
- Predicates its devices cite: 24 (19 its own); citations of its devices by later devices: 34 (19 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sysmex Corp.: 1 (https://510kreport.com/company/sysmex)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Siemens Healthcare Diagnostic Products GmbH: 1 (https://510kreport.com/company/siemens-healthcare-diagnostic-products)
- Streck Laboratories, Inc.: 1 (https://510kreport.com/company/streck-laboratories)
- Triangle Biomedical Sciences, Inc.: 1 (https://510kreport.com/company/triangle-biomedical-sciences)

## Firms that cite its devices most
- Horiba Abx: 2 (https://510kreport.com/company/horiba-abx)
- Arkray, Inc.: 2 (https://510kreport.com/company/arkray)
- Sight Diagnostics, Ltd.: 1 (https://510kreport.com/company/sight-diagnostics)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Iris Diagnostics: 1 (https://510kreport.com/company/iris-diagnostics)
- Hemocue, Inc.: 1 (https://510kreport.com/company/hemocue)
- Advanced Instruments, Inc.: 1 (https://510kreport.com/company/advanced-instruments)
- Cytochip, Inc.: 1 (https://510kreport.com/company/cytochip)

## Its most-cited devices
- K112605: Sysmex XN-Series (2012), cited by 13
- K070910: Sysmex Model UF1000I (2007), cited by 4
- K071967: Sysmex XE-5000 (2007), cited by 4
- K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software (2008), cited by 2
- K040073: Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) (2004), cited by 2
- K250943: Sysmex XR-Series (XR-10) Automated Hematology Analyzer (2025), cited by 1

## Recent decisions
- K253212: XR-Series (XR-10, XR-20) Automated Hematology Analyzers (May 27, 2026)
- K250943: Sysmex XR-Series (XR-10) Automated Hematology Analyzer (Jun 25, 2025)
- K251371: Sysmex XR-Series (XR-20) Automated Hematology Analyzer (Jun 25, 2025)
- K250965: Automated Blood Coagulation Analyzer CN-Series (CN-6000) (Jun 2, 2025)
- K230887: Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (Dec 21, 2023)
- K210346: Sysmex XW-100 Automated Hematology Analyzer (Nov 8, 2022)
- K182389: Sysmex XN-L Automated Hematology Analyzer (Jan 25, 2019)
- K182062: Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (Oct 30, 2018)

Source page: https://510kreport.com/company/sysmex-america