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FDA 510(k)

Lilium one (USM330)

K-Number: K260605 · 2026-10-16

ApplicantLilium Otsuka Co., Ltd.
Decision Date2026-10-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lilium one (USM330) is the device name listed in this FDA 510(k) record. The listed applicant is Lilium Otsuka Co., Ltd.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K260605. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lilium one (USM330)?

Lilium one (USM330) is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Lilium Otsuka Co., Ltd.. The 510(k) number is K260605.

When did Lilium one (USM330) receive FDA 510(k) clearance?

Lilium one (USM330) received FDA 510(k) clearance on 2026-10-16, under 510(k) number K260605.

Who is the listed applicant for Lilium one (USM330)?

The FDA 510(k) record lists Lilium Otsuka Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lilium one (USM330)?

The FDA product code for Lilium one (USM330) is IYO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Lilium Otsuka Co., Ltd. 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.

K170046Lilium a-200E

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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