Sysmex Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Sysmex Corp.” (first 1979, latest 2001), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 102 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 4 | 4 |
| GKZ | Counter, Differential Cell | 4 | 4 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 3 | 3 |
| LKM | Counter, Urine Particle | 2 | 2 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
| GKR | System, Hemoglobin, Automated | 1 | 1 |
| JRQ | Shaker/Stirrer | 1 | 1 |
Review panels
- Hematology (16)
- Clinical Chemistry (1)
- General Hospital (1)
Most recent Sysmex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012372 | SYSMEX UF-50 | LKM | 2001-09-28 | 64 |
| K992875 | SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER | GKZ | 1999-11-09 | 75 |
| K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | GKL | 1998-11-03 | 153 |
| K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | GKL | 1998-08-14 | 87 |
| K971736 | SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER | GKZ | 1997-08-26 | 106 |
| K964946 | SYSMEX CA-1000/SYSMEX CA-5000 | JPA | 1997-03-18 | 98 |
| K964375 | SYSMEX SE/RAM-1 | GKL | 1997-03-13 | 132 |
| K961054 | SYSMEX UF-100 | LKM | 1996-10-28 | 224 |
| K950508 | SYSMEX SF-3000 | FPK | 1995-11-03 | 270 |
| K945837 | SYSMEX(TM) F-820, 520 | GKZ | 1995-06-09 | 192 |
8 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-12-18.
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.
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 America, Inc. (31 510(k)s)
- Sysmex Corporation of America (3 510(k)s)
- Sysmex/Toa Medical Electronics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sysmex Corp.?
FDA lists 18 510(k) clearances under the applicant name “Sysmex Corp.” (first 1979, latest 2001), across 9 product codes in 3 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sysmex Corp. is 102 days.
Which FDA product codes appear under Sysmex Corp.?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 4); GKZ (Counter, Differential Cell, 4); JPA (System, Multipurpose For In Vitro Coagulation Studies, 3).
Next steps
- See all 18 Sysmex Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Sysmex Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.