Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kitazato Biopharma Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
454 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit | Kitazato Biopharma Co., Ltd. | 2016-10-07 | 192 | 0 |
| K160863 | PBS(-), Phosphate Buffered Saline | Kitazato Biopharma Co., Ltd. | 2016-07-28 | 121 | 0 |
| K160142 | MINERAL OIL | Kitazato Biopharma Co., Ltd. | 2016-04-21 | 91 | 0 |
| K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016-03-14 | 150 | 0 |
| K140072 | CRYOTOP(R) SC | Kitazato Biopharma Co., Ltd. | 2014-04-03 | 80 | 0 |
| K112695 | CRYOTOP | Kitazato Biopharma Co;Ltd | 2012-12-12 | 454 | 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