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FDA 510(k)

Fast Warm - NX

K-Number: K250445 · 2025-09-12

ApplicantFujifilm Irvine Scientific
Decision Date2025-09-12
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fast Warm - NX is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K250445. 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 Fast Warm - NX?

Fast Warm - NX is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K250445.

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

Fast Warm - NX received FDA 510(k) clearance on 2025-09-12, under 510(k) number K250445.

Who is the listed applicant for Fast Warm - NX?

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

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

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

Other records listing Fujifilm Irvine Scientific 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.

K241341cryo-GO Vitrification DeviceK233764SSS-NX (Serum Substitute Supplement-NX)K231804PRIME-XV FreezIS DMSO-Free MDK190152Vit Kit- Freeze NX and Vit Kit- Warm NX

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.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.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 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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