Lilium one (USM330)— 510(k) K260605

Name: FDA 510(k) clearance K260605
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Lilium Otsuka Co., Ltd.

FDA 510(k) clearance K260605 for Lilium one (USM330), Substantially Equivalent on 2026-10-16. Applicant: Lilium Otsuka Co., Ltd.. Device class: 2.

Clearance details

Applicant: Lilium Otsuka Co., Ltd.
Product code: Product code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2026-02-24
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanagawa, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K261648 — Evident Vascular Guidance System2026-10-28
K262093 — Accuro XV2026-10-20
K260313 — MD-6000S Bladder Scanner2026-09-24
K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18

More clearances from Lilium Otsuka Co., Ltd.

view all

K170046 — Lilium a-200E2017-12-07

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.