FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Ultra-Fast Vitri; Ultra-Fast Warm
K Number: K251305
·
Decision Aug 26, 2025
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
13
Review Days
120
Basic Information
- Device Name
- Ultra-Fast Vitri; Ultra-Fast Warm
- K Number
- K251305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kitazato Corporation
- Date Received
- April 28, 2025
- Decision Date
- August 26, 2025
- Product Code
- MQL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.
Ultra-Fast Warm
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FDA Class 2
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FDA 510(k)
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Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
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FDA Class 2
·Obstetrics/Gynecology
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
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FDA Class 2
·Obstetrics/Gynecology
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Kitazato Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260248 | Ultra-Fast Warm | Apr 28, 2026 | 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]) | Oct 23, 2020 | Substantially Equivalent |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Aug 25, 2020 | Substantially Equivalent |
| K192845 | Sperm Freeze, Sperm Fridge | Aug 17, 2020 | Substantially Equivalent |
| K192540 | Kitazato ET Catheters | May 1, 2020 | Substantially Equivalent |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | Sep 26, 2019 | Substantially Equivalent |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Nov 9, 2018 | Substantially Equivalent |
| K182002 | Cumulus Remover | Oct 23, 2018 | Substantially Equivalent |
| K171748 | Vitrification Kit and Thawing Kit | Dec 14, 2017 | Substantially Equivalent |
| K162878 | Kitazato ET Catheters | Jul 13, 2017 | Substantially Equivalent |