Data / Medical devices / Switzerland / Cascination

Cascination: FDA-registered device maker in Bern, Switzerland, 7 510(k) clearances

Name: Cascination FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cascination is registered with the FDA (registration 3011797532) in Bern, Switzerland. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011797532
Address: Steigerhubelstrasse 3, Bern, Switzerland, 3008
Owner or operator: CASCINATION AG (10049564)
Roles: Manufacturer
First device listed: June 19, 2015
Registered through: 2026
Brand names listed: CAS-One IR, CAS-One IR System, CAS-One IR system, CAS-One Liver system, OTOPLAN, Otoplan, Otoplan 2

Devices it lists

Device	Product code	Class	Role	Source
Image Management Software For Planning Of Otologic And Neurotologic Procedures	QQE	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov
Tracking, Soft Tissue, Intraoperative	OEW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 29, 2026	K261225	CAS-One IR	JAK	Substantially Equivalent	Cascination AG	accessdata.fda.gov
April 11, 2025	K242120	OTOPLAN	QQE	Substantially Equivalent	Cascination AG	accessdata.fda.gov
March 13, 2024	K232022	CAS-One IR	JAK	Substantially Equivalent	Cascination AG	accessdata.fda.gov
June 24, 2022	K220300	OTOPLAN	QQE	Substantially Equivalent	Cascination AG	accessdata.fda.gov
August 20, 2021	K203486	Otoplan	QQE	Substantially Equivalent	Cascination AG	accessdata.fda.gov
January 20, 2016	K152473	CAS-One IR	JAK	Substantially Equivalent	Cascination AG	accessdata.fda.gov
April 28, 2015	K143024	CAS-One Liver	OEW	Substantially Equivalent	Cascination AG	accessdata.fda.gov

Compare with other makers

Updated September 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.