Kitazato Corporation FDA Record
- Latest inspection NAI · Apr 16, 2015
- No warning letters matched by name
Kitazato Corporation has 0 FDA recalls, 1 inspection, 13 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kitazato Corporation" is on file.
- Latest inspection
- Apr 16, 2015 · NAI
- Latest 510(k)
- Apr 28, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 13 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 16, 2015 | Fuji, Japan | Devices | No Action Indicated (NAI) | 3008876063 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008876063 | Fuji, Japan | 1 | Apr 16, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K260248 | Ultra-Fast Warm | Apr 28, 2026 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Aug 26, 2025 |
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage… | Oct 23, 2020 |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Aug 25, 2020 |
| K192845 | Sperm Freeze, Sperm Fridge | Aug 17, 2020 |
| K192540 | Kitazato ET Catheters | May 1, 2020 |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | Sep 26, 2019 |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Nov 9, 2018 |
| K182002 | Cumulus Remover | Oct 23, 2018 |
| K171748 | Vitrification Kit and Thawing Kit | Dec 14, 2017 |
| K162878 | Kitazato ET Catheters | Jul 13, 2017 |
| K162881 | Kitazato OPU Needles | Jul 11, 2017 |
| K162667 | Kitazato IUI Catheter | May 11, 2017 |
Kitazato Corporation and the FDA: common questions
Has Kitazato Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Kitazato Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Kitazato Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Kitazato Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kitazato Corporation?
The most recent FDA inspection on file ended Apr 16, 2015 at Fuji, Japan and was classified NAI. FDA has 1 inspection of Kitazato Corporation on file.
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