Kitazato Corporation
Minato-ku, JP
KITAZATO CORPORATION appears in FDA device records in Minato-ku, JP. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Kitazato Corporation between 2017 and 2026. The busiest year on record is 2017, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260248 | Ultra-Fast Warm | MQL | Substantially Equivalent | |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | MQL | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | MQL | Substantially Equivalent | |
| K192845 | Sperm Freeze, Sperm Fridge | MQL | Substantially Equivalent | |
| K192540 | Kitazato ET Catheters | MQF | Substantially Equivalent | |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | MQL | Substantially Equivalent | |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | MQK | Substantially Equivalent | |
| K182002 | Cumulus Remover | MQL | Substantially Equivalent | |
| K171748 | Vitrification Kit and Thawing Kit | MQL | Substantially Equivalent | |
| K162878 | Kitazato ET Catheters | MQF | Substantially Equivalent | |
| K162881 | Kitazato OPU Needles | MQE | Substantially Equivalent | |
| K162667 | Kitazato IUI Catheter | MQF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008876063 | 3008876063 | KITAZATO CORPORATION | 100-10 Yanagishima, Fuji Shizuoka 416-0932 JP | 2026 | |
| 3008456389 | 3008456389 | Kitazato Corporation | 1-1-8 Shibadaimon, Minato-ku Tokyo 105-0012 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain