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=K262080

OTOPLAN (K262080): 510(k) cleared for Cascination AG

Q: How to monitor OTOPLAN (K262080): 510(k) cleared for Cascination AG and peer radiology records

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OTOPLAN (K262080): 510(k) cleared for Cascination AG: 510(k) cleared for Cascination AG. Its amount of 123 is below the median of 138 (46th percentile). Dated 12 days ago, it is in the active follow-up window. Score 42/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 123 · 46th percentile of 414 FDAPulse records · 0.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 6 related CH FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K262080
Device	OTOPLAN
Applicant	Cascination AG
Specialty / panel	Radiology
Product code	QQE
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-06-22
Decision date	2026-10-23
Review time (days)	123
Third-party review	No
Applicant location	Bern, CH
amount percentile	46th of 414 (median 138, 0.9x median)
Peer records CSV (7 CH records)	🔒 Click to unlock →
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-23
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: OTOPLAN (K262080): 510(k) cleared for Cascination AG and 7 CH peers

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

CH FDAPulse records like this one: 7
OTOPLAN (K262080): 510(k) cleared for Cascination AG's amount: 46th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every CH peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

42 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 123-day review: this device is a strong predicate for similar products.
Posted 12 days ago.

What is the FDAPulse record for OTOPLAN (K262080): 510(k) cleared for Cascination AG?

OTOPLAN (K262080) by Cascination AG was cleared on 2026-10-23 after 123 days of review.

How does OTOPLAN (K262080): 510(k) cleared for Cascination AG compare to other FDAPulse records?

Its amount of 123 is below the median (46th percentile); smaller records often move faster and face less competition. It is fresh: dated 12 days ago, inside the window where early outreach matters most.

OTOPLAN (K262080) vs. top 3 peers

Organization	Location	Record date
OTOPLAN (K262080)	CH	2026-10-23
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 OTOPLAN (K262080): 510(k) cleared for Cascination AG and peer radiology records

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