FDA 510(k)

Ultra-Fast Warm

Número K: K260248 · 2026-04-28

Data da decisão2026-04-28

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Kitazato Corporation como candidato(a)

K251305Ultra-Fast Vitri; Ultra-Fast Warm K200249Sequential 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 rHA K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters K190199SepaSperm Washing Solution, SepaSperm Solution

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 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 Corporation K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Fonte oficial

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