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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / May 2026 / K253837

510(k) cleared

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module

Heidelberg Engineering GmbH · May 7, 2026 · K253837

FDA cleared the SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module from Heidelberg Engineering GmbH on May 7, 2026 under K253837, 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 Dec 1, 2025. The decision came 157 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: K261019 (ANTERION).

Questions & Answers

What did FDA clear under K253837?

K253837 is the FDA 510(k) for SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module, submitted by Heidelberg Engineering GmbH. FDA's decision date was May 7, 2026, under product code OBO (Tomography, Optical Coherence).

Who makes the SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module?

Heidelberg Engineering GmbH, based in Heidelberg, is the applicant of record for K253837.

How long did the K253837 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on May 7, 2026, 157 days later.

← All decisions in May 2026

Sources