Kitazato Biopharma Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kitazato Biopharma Co., Ltd.” (first 2014, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 121 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 80 |
| 2015 | 0 | — |
| 2016 | 4 | 136 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 3 | 3 |
| MQK | Labware, Assisted Reproduction | 2 | 2 |
Review panels
Most recent Kitazato Biopharma Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit | MQL | 2016-10-07 | 192 |
| K160863 | PBS(-), Phosphate Buffered Saline | MQL | 2016-07-28 | 121 |
| K160142 | MINERAL OIL | MQL | 2016-04-21 | 91 |
| K153027 | Cryotop US | MQK | 2016-03-14 | 150 |
| K140072 | CRYOTOP(R) SC | MQK | 2014-04-03 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Kitazato Biopharma Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kitazato Corporation (13 510(k)s)
- Kitazato Medical Co., Ltd. (3 510(k)s)
- Kitazato Biopharma Co;Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kitazato Biopharma Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Kitazato Biopharma Co., Ltd.” (first 2014, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kitazato Biopharma Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kitazato Biopharma Co., Ltd. is 121 days.
Which FDA product codes appear under Kitazato Biopharma Co., Ltd.?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 3); MQK (Labware, Assisted Reproduction, 2).
Next steps
- See all 5 Kitazato Biopharma Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQL, Kitazato Biopharma Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.