Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Denka Seiken Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
427 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161679 | s LDL-EX SEIKEN | Denka Seiken Co., Ltd. | 2017-08-18 | 427 | 0 |
| K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006-04-14 | 60 | 0 |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2005-01-26 | 63 | 0 |
| K041090 | HDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2004-10-29 | 186 | 0 |
| K030546 | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | 2003-06-02 | 102 | 0 |
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2003-06-02 | 102 | 1 |
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