Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suzuken Co., Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
290 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172068 | Kenz Cardico1211 | Suzuken Co., Ltd. | 2018-06-01 | 329 | 0 |
| K101024 | KENZ CARDY302 MAX | Suzuken Co., Ltd. | 2011-01-06 | 268 | 0 |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | 2009-10-13 | 69 | 0 |
| K001896 | KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KEN | Suzuken Co., Ltd. | 2001-01-08 | 201 | 0 |
| K870443 | KENZ-CARDICO 1201 | Suzuken Co., Ltd. | 1987-07-01 | 148 | 0 |
| K862544 | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH | Suzuken Co., Ltd. | 1986-08-06 | 34 | 0 |
| K843731 | KENZ 80Z MARK II | Suzuken Co., Ltd. | 1985-07-11 | 290 | 0 |
| K822968 | ELECTROCARDIOGRAPH INTERPRETER | Suzuken Co., Ltd. | 1982-12-15 | 69 | 0 |
| K820854 | KENZ-45M | Suzuken Co., Ltd. | 1982-06-01 | 67 | 0 |
| K820991 | KENZ-GELECT GEL PAD | Suzuken Co., Ltd. | 1982-04-26 | 18 | 0 |
| K812263 | KENZ-GELECT | Suzuken Co., Ltd. | 1981-11-02 | 81 | 0 |
| K811949 | KENL-ECG-3 | Suzuken Co., Ltd. | 1981-08-13 | 37 | 0 |
| K811950 | KENL-ECG | Suzuken Co., Ltd. | 1981-08-13 | 37 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda