Sysmex America, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Sysmex America, Inc.” (first 2003, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 100 days. Since 2017 the median was 116 days, against 222 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 408 |
| 2013 | 0 | — |
| 2014 | 1 | 165 |
| 2015 | 1 | 299 |
| 2016 | 2 | 269 |
| 2017 | 1 | 68 |
| 2018 | 2 | 197 |
| 2019 | 1 | 143 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 638 |
| 2023 | 1 | 265 |
| 2024 | 0 | — |
| 2025 | 3 | 63 |
| 2026 | 1 | 240 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sysmex America, Inc. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 222 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 22 | 22 |
| LKM | Counter, Urine Particle | 5 | 5 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JOY | Device, Automated Cell-Locating | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
Review panels
- Hematology (30)
- Clinical Chemistry (1)
Most recent Sysmex America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | GKZ | 2026-05-27 | 240 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | GKZ | 2025-06-25 | 54 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | GKZ | 2025-06-25 | 89 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | JPA | 2025-06-02 | 63 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | GKZ | 2023-12-21 | 265 |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | GKZ | 2022-11-08 | 638 |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | GKZ | 2019-01-25 | 143 |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | JOY | 2018-10-30 | 90 |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | LKM | 2018-04-23 | 304 |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | GKZ | 2017-11-06 | 68 |
21 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 14 recall events; 2 initiated in the last five years. Most recent: 2025-12-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Sysmex America, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01368744: Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology (Completed, started 2010-03)
- NCT01136369: Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer (Completed, started 2007-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sysmex Corp. (18 510(k)s)
- Sysmex Corporation of America (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sysmex America, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Sysmex America, Inc.” (first 2003, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sysmex America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sysmex America, Inc. is 100 days. Since 2017: 116 days, versus 222 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sysmex America, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 22); LKM (Counter, Urine Particle, 5); GKL (Counter, Cell, Automated (Particle Counter), 1).
Next steps
- See all 31 Sysmex America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Sysmex America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.