WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262080

510(k) cleared

OTOPLAN

Cascination AG · Oct 23, 2026 · K262080

FDA cleared the OTOPLAN from Cascination AG on Oct 23, 2026 under K262080, a traditional 510(k). The device falls under product code QQE, Image Management Software For Planning Of Otologic And Neurotologic Procedures, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 22, 2026. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cascination AG has one other decision in the tracker over the last 12 months: K261225 (CAS-One IR).

Questions & Answers

What did FDA clear under K262080?

K262080 is the FDA 510(k) for OTOPLAN, submitted by Cascination AG. FDA's decision date was Oct 23, 2026, under product code QQE (Image Management Software For Planning Of Otologic And Neurotologic Procedures).

Who makes the OTOPLAN?

Cascination AG, based in Bern, is the applicant of record for K262080.

How long did the K262080 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Oct 23, 2026, 123 days later.

← All decisions in October 2026

Sources