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The Tracker / October 2026 / K260605

510(k) cleared

Lilium one (USM330)

Lilium Otsuka Co., Ltd. · Oct 16, 2026 · K260605

FDA cleared the Lilium one (USM330) from Lilium Otsuka Co., Ltd. on Oct 16, 2026 under K260605, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 24, 2026. The decision came 234 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 Lilium Otsuka Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260605?

K260605 is the FDA 510(k) for Lilium one (USM330), submitted by Lilium Otsuka Co., Ltd.. FDA's decision date was Oct 16, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the Lilium one (USM330)?

Lilium Otsuka Co., Ltd., based in Kanagawa, is the applicant of record for K260605.

How long did the K260605 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Oct 16, 2026, 234 days later.

← All decisions in October 2026