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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K250445

510(k) cleared

Fast Warm - NX

Fujifilm Irvine Scientific · Sep 12, 2025 · K250445

FDA cleared the Fast Warm - NX from Fujifilm Irvine Scientific on Sep 12, 2025 under K250445, a traditional 510(k). The device falls under product code MQL, Media, Reproductive, regulated at 21 CFR 884.6180 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Feb 14, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Fujifilm Irvine Scientific in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250445?

K250445 is the FDA 510(k) for Fast Warm - NX, submitted by Fujifilm Irvine Scientific. FDA's decision date was Sep 12, 2025, under product code MQL (Media, Reproductive).

Who makes the Fast Warm - NX?

Fujifilm Irvine Scientific, based in Santa Ana, CA, is the applicant of record for K250445.

How long did the K250445 review take?

FDA received the submission on Feb 14, 2025 and issued its decision on Sep 12, 2025, 210 days later.

← All decisions in September 2025