Toa Medical Electronics USA, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Toa Medical Electronics USA, Inc.” (first 1978, latest 1994), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 81 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) | 15 | 15 |
| GKZ | Counter, Differential Cell | 11 | 11 |
| GIF | Diluent, Blood Cell | 2 | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 2 |
| GKH | Apparatus, Automated Blood Cell Diluting | 1 | 1 |
| GKR | System, Hemoglobin, Automated | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (32)
Most recent Toa Medical Electronics USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K936023 | SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER | GKZ | 1994-05-02 | 138 |
| K933886 | TOA MEDICAL ELECTRONICS CA-5000 | JPA | 1994-01-27 | 170 |
| K931149 | CA-1000 AUTOMATED COAGULATION ANALYZER | JPA | 1993-11-03 | 240 |
| K920544 | SYSMEX HEMATOLOGY SYSTEM ACCESSORIES | GKZ | 1992-04-29 | 83 |
| K914744 | SYSMEX NE-1500, MODIFICATION | GKZ | 1991-12-30 | 69 |
| K912494 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER | GKL | 1991-09-10 | 97 |
| K911173 | SYSMEX F-310 | GKL | 1991-07-26 | 149 |
| K911172 | SYSMEX F-610 | GKL | 1991-07-26 | 149 |
| K910849 | SYSMEX F-810 | GKL | 1991-07-26 | 149 |
| K910745 | HEMOGLOBIN REAGENT | GKR | 1991-07-11 | 140 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Toa Medical Electronics USA, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Toa Medical Electronics USA, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Toa Medical Electronics USA, Inc.” (first 1978, latest 1994), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Toa Medical Electronics USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Toa Medical Electronics USA, Inc. is 81 days.
Which FDA product codes appear under Toa Medical Electronics USA, Inc.?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 15); GKZ (Counter, Differential Cell, 11); GIF (Diluent, Blood Cell, 2).
Next steps
- See all 33 Toa Medical Electronics USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Toa Medical Electronics USA, 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.