Kitazato Corporation: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Kitazato Corporation” (first 2017, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 228 days. Since 2017 the median was 228 days, against 197 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 4 | 248 |
| 2018 | 2 | 124 |
| 2019 | 1 | 234 |
| 2020 | 4 | 256 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 120 |
| 2026 | 1 | 91 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kitazato Corporation took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 8 | 8 |
| MQF | Catheter, Assisted Reproduction | 3 | 3 |
| MQE | Needle, Assisted Reproduction | 1 | 1 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Kitazato Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260248 | Ultra-Fast Warm | MQL | 2026-04-28 | 91 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | MQL | 2025-08-26 | 120 |
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) | MQL | 2020-10-23 | 263 |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | MQL | 2020-08-25 | 250 |
| K192845 | Sperm Freeze, Sperm Fridge | MQL | 2020-08-17 | 319 |
| K192540 | Kitazato ET Catheters | MQF | 2020-05-01 | 228 |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | MQL | 2019-09-26 | 234 |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | MQK | 2018-11-09 | 158 |
| K182002 | Cumulus Remover | MQL | 2018-10-23 | 89 |
| K171748 | Vitrification Kit and Thawing Kit | MQL | 2017-12-14 | 184 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kitazato Corporation.
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 Biopharma Co., Ltd. (5 510(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 Corporation?
FDA lists 13 510(k) clearances under the applicant name “Kitazato Corporation” (first 2017, latest 2026), across 4 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 Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kitazato Corporation is 228 days. Since 2017: 228 days, versus 197 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kitazato Corporation?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 8); MQF (Catheter, Assisted Reproduction, 3); MQE (Needle, Assisted Reproduction, 1).
Next steps
- See all 13 Kitazato Corporation clearances with predicates and recalls
- Run predicate analysis for product code MQL, Kitazato Corporation'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.