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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 / April 2026 / K260248

510(k) cleared

Ultra-Fast Warm

Kitazato Corporation · Apr 28, 2026 · K260248

FDA cleared the Ultra-Fast Warm from Kitazato Corporation on Apr 28, 2026 under K260248, 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 Jan 27, 2026. The decision came 91 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 Kitazato Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260248?

K260248 is the FDA 510(k) for Ultra-Fast Warm, submitted by Kitazato Corporation. FDA's decision date was Apr 28, 2026, under product code MQL (Media, Reproductive).

Who makes the Ultra-Fast Warm?

Kitazato Corporation, based in Fuji, is the applicant of record for K260248.

How long did the K260248 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Apr 28, 2026, 91 days later.

← All decisions in April 2026