Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sakura Seiki 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) |
|---|---|---|---|---|---|
| K132439 | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW | Sakura Seiki Co., Ltd. | 2014-01-06 | 154 | 0 |
| K122774 | SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERI | Sakura Seiki Co., Ltd. | 2013-05-09 | 241 | 0 |
| K120149 | SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 | Sakura Seiki Co., Ltd. | 2012-05-08 | 111 | 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