Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260605

Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.

Q: How to monitor Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. and peer radiology records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.: 510(k) cleared for Lilium Otsuka Co., Ltd. Its amount of 234 is above the median of 138 (75th percentile). Dated 20 days ago, it is in the active follow-up window. Score 53/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 234 · 75th percentile of 414 FDAPulse records · 1.7x the median

Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K260605
Device	Lilium one (USM330)
Applicant	Lilium Otsuka Co., Ltd.
Specialty / panel	Radiology
Product code	IYO
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-02-24
Decision date	2026-10-16
Review time (days)	234
Third-party review	Yes
Applicant location	Kanagawa, JP
amount percentile	75th of 414 (median 138, 1.7x median)
Peer records CSV (10 JP records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

View the official record

Markdown version

Watch Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.

Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.

Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.

Unlock Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co. + all 10 JP records (CSV)

Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL

Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-16
Data refreshed: 2026-11-04
Refunds on request within 14 days

Search all JP records free →

Top FDAPulse records (JP first): SCENARIA View Phase 6.0 (K261229) · APERTO Lucent MRI System (K261283) · KOWA FM-600 (K261255) · DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece ( · TSK OptiXion (K262516) · Browse all by state and category →

LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

Is this your business? Add a "Listed on Zalwin" badge to your site

Paste this snippet into your website. It links to this public record; nothing is tracked on your site.

<a href="https://zalwin.com/report/fdapulse/lilium-one-usm330-k260605-jp--k260605" rel="noopener"><img src="https://zalwin.com/badge/listed.svg" alt="Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. on Zalwin public records" width="150" height="28"></a>

Peer benchmark and outreach value: Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. and 10 JP peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

JP FDAPulse records like this one: 10
Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.'s amount: 75th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

53 / 100 Predicate Speed & CAPA Advisory Opportunity Score

234-day review, longer than typical.
Reviewed through the third-party program.
Posted 20 days ago.

What is the FDAPulse record for Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.?

Lilium one (USM330) (K260605) by Lilium Otsuka Co., Ltd. was cleared on 2026-10-16 after 234 days of review.

How does Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. compare to other FDAPulse records?

Its amount of 234 sits in the upper half (75th percentile) of 414 records; the median is 138. It is 20 days old, still within a typical 45-day follow-up window.

Lilium one (USM330) (K260605) vs. top 3 peers

Organization	Location	Record date
Lilium one (USM330) (K260605)	JP	2026-10-16
VenusCT (K260510)	CA	2026-10-19
AVIEW Aorta Metrics (K260391)	KR	2026-10-16
Vista AI Scan (K260092)	CA	2026-10-07

How to monitor Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. and peer radiology records

Get new FDAPulse records like Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. by email (free, weekly)

We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.

Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.

See this week's digest

Get clearances and recalls like this every day

FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.

See plans

✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

Often used together

Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.