Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wako Pure Chemical Industries, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
54 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842221 | WAKO GLUCOSE C | Wako Pure Chemical Industries, Ltd. | 1984-07-12 | 37 | 0 |
| K813366 | AMMONIA TEST | Wako Pure Chemical Industries, Ltd. | 1981-12-22 | 22 | 0 |
| K801834 | WAKO HDL CHOLESTEROL TEST | Wako Pure Chemical Industries, Ltd. | 1980-09-16 | 46 | 0 |
| K801891 | WAKO TRIGLYCERIDE-G TEST | Wako Pure Chemical Industries, Ltd. | 1980-09-16 | 39 | 0 |
| K801076 | WAKO PHOSPHOLIPIDS TEST | Wako Pure Chemical Industries, Ltd. | 1980-06-30 | 54 | 0 |
| K791597 | WAKO TRIGLYCERIDE | Wako Pure Chemical Industries, Ltd. | 1979-09-17 | 33 | 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