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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

This is the only decision on file for Heidelberg Engineering GmbH in the last 12 months of the tracker.

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