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FDA 510(k)

Ultra-Fast Vitri; Ultra-Fast Warm

K-Number: K251305 · 2025-08-26

ApplicantKitazato Corporation
Decision Date2025-08-26
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ultra-Fast Vitri; Ultra-Fast Warm is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2025-08-26 under approval number K251305. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultra-Fast Vitri; Ultra-Fast Warm?

Ultra-Fast Vitri; Ultra-Fast Warm is a medical device that received FDA 510(k) clearance on 2025-08-26. It is manufactured by Kitazato Corporation. The 510(k) number is K251305.

When was Ultra-Fast Vitri; Ultra-Fast Warm approved by the FDA?

Ultra-Fast Vitri; Ultra-Fast Warm received FDA 510(k) clearance on 2025-08-26, under approval number K251305.

What company makes Ultra-Fast Vitri; Ultra-Fast Warm?

Ultra-Fast Vitri; Ultra-Fast Warm is manufactured by Kitazato Corporation.

What is the FDA product code for Ultra-Fast Vitri; Ultra-Fast Warm?

The FDA product code for Ultra-Fast Vitri; Ultra-Fast Warm is MQL.

Other Devices by Kitazato Corporation

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Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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