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FDA 510(k)

Ultra-Fast Warm

K-Number: K260248 · 2026-04-28

ApplicantKitazato Corporation
Decision Date2026-04-28
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ultra-Fast Warm is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K260248. 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 Warm?

Ultra-Fast Warm is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Kitazato Corporation. The 510(k) number is K260248.

When did Ultra-Fast Warm receive FDA 510(k) clearance?

Ultra-Fast Warm received FDA 510(k) clearance on 2026-04-28, under 510(k) number K260248.

Who is the listed applicant for Ultra-Fast Warm?

The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kitazato Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251305Ultra-Fast Vitri; Ultra-Fast WarmK200249Sequential 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])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAK192845Sperm Freeze, Sperm FridgeK192540Kitazato ET CathetersK190199SepaSperm Washing Solution, SepaSperm Solution

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Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NVK242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)Donnevie Medical Technology (Shanghai) Co. , 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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