Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sakura Finetek U.S.A., Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893811 | SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM | Sakura Finetek U.S.A., Inc. | 1989-09-07 | 108 | 0 |
| K882881 | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | Sakura Finetek U.S.A., Inc. | 1988-07-28 | 17 | 0 |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Sakura Finetek U.S.A., Inc. | 1988-07-01 | 103 | 0 |
| K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | Sakura Finetek U.S.A., Inc. | 1988-01-05 | 35 | 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