Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kyoto Daiichi Kagaku Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870708 | GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM | Kyoto Daiichi Kagaku Co., Ltd. | 1988-02-02 | 347 | 0 |
| K870526 | SUPER URINE ANALYZER SYSTEM | Kyoto Daiichi Kagaku Co., Ltd. | 1987-03-06 | 28 | 0 |
| K813056 | AUTOMATED URINALYSIS SYSTEM | Kyoto Daiichi Kagaku Co., Ltd. | 1982-05-05 | 188 | 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