Suzuken Co., Ltd.: FDA clearances and approvals
Suzuken Co., Ltd. has 13 FDA 510(k) clearances (first 1981, latest 2018), across 7 product codes in 2 review panels. Median 510(k) review time: 69 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 329 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Suzuken Co., Ltd.'s cleared 510(k)s took a median 329 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 5 | 5 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| GYB | Media, Electroconductive | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| LOS | 1 | 1 | |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (10)
- Neurology (2)
Most recent Suzuken Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172068 | Kenz Cardico1211 | DPS | 2018-06-01 | 329 |
| K101024 | KENZ CARDY302 MAX | MWJ | 2011-01-06 | 268 |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | DRX | 2009-10-13 | 69 |
| K001896 | KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC | DPS | 2001-01-08 | 201 |
| K870443 | KENZ-CARDICO 1201 | LOS | 1987-07-01 | 148 |
| K862544 | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH | DPS | 1986-08-06 | 34 |
| K843731 | KENZ 80Z MARK II | DSI | 1985-07-11 | 290 |
| K822968 | ELECTROCARDIOGRAPH INTERPRETER | DSI | 1982-12-15 | 69 |
| K820854 | KENZ-45M | DXN | 1982-06-01 | 67 |
| K820991 | KENZ-GELECT GEL PAD | GYB | 1982-04-26 | 18 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Suzuken Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Suzuken Co., Ltd. have?
Suzuken Co., Ltd. has 13 FDA 510(k) clearances (first 1981, latest 2018), across 7 product codes in 2 review panels.
How long does FDA take to clear Suzuken Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Suzuken Co., Ltd.'s cleared 510(k)s is 69 days.
What devices does Suzuken Co., Ltd. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 5); DSI (Detector And Alarm, Arrhythmia, 2); GYB (Media, Electroconductive, 2).
Has Suzuken Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Suzuken Co., Ltd. Related entities may recall under other names.
Next steps
- See all 13 Suzuken Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Suzuken Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.