FDA 510(k)

Fast Warm - NX

K-Number: K250445 · 2025-09-12

Decision Date2025-09-12

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Fast Warm - NX is a medical device manufactured by Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2025-09-12 under approval 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. It is manufactured by Fujifilm Irvine Scientific. The 510(k) number is K250445.

When was Fast Warm - NX approved by the FDA?

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

What company makes Fast Warm - NX?

Fast Warm - NX is manufactured by Fujifilm Irvine Scientific.

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

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

Other Devices by Fujifilm Irvine Scientific

K231804PRIME-XV FreezIS DMSO-Free MD K241341cryo-GO Vitrification Device K233764SSS-NX (Serum Substitute Supplement-NX)

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.