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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261019

510(k) cleared

ANTERION

Heidelberg Engineering GmbH · Sep 11, 2026 · K261019

FDA cleared the ANTERION from Heidelberg Engineering GmbH on Sep 11, 2026 under K261019, a traditional 510(k). The device falls under product code OBO, Tomography, Optical Coherence, regulated at 21 CFR 886.1570 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Mar 27, 2026. The decision came 168 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Heidelberg Engineering GmbH has one other decision in the tracker over the last 12 months: K253837 (SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module).

Questions & Answers

What did FDA clear under K261019?

K261019 is the FDA 510(k) for ANTERION, submitted by Heidelberg Engineering GmbH. FDA's decision date was Sep 11, 2026, under product code OBO (Tomography, Optical Coherence).

Who makes the ANTERION?

Heidelberg Engineering GmbH, based in Heidelberg, is the applicant of record for K261019.

How long did the K261019 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Sep 11, 2026, 168 days later.

← All decisions in September 2026

Sources