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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 / March 2026 / K253668

510(k) cleared

Onera SleepMap (SLEEPMAP)

Onera B.V. · Mar 8, 2026 · K253668

FDA cleared the Onera SleepMap (SLEEPMAP) from Onera B.V. on Mar 8, 2026 under K253668, a traditional 510(k). The device falls under product code OLZ, Automatic Event Detection Software For Polysomnograph With Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 21, 2025. The decision came 107 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 Onera B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253668?

K253668 is the FDA 510(k) for Onera SleepMap (SLEEPMAP), submitted by Onera B.V.. FDA's decision date was Mar 8, 2026, under product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

Who makes the Onera SleepMap (SLEEPMAP)?

Onera B.V., based in Eindhoven, is the applicant of record for K253668.

How long did the K253668 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Mar 8, 2026, 107 days later.

← All decisions in March 2026