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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 / June 2026 / K253390

510(k) cleared

SOMNUM (SOMNUM)

Honeynaps Co., Ltd. · Jun 27, 2026 · K253390

FDA cleared the SOMNUM (SOMNUM) from Honeynaps Co., Ltd. on Jun 27, 2026 under K253390, 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 Sep 30, 2025. The decision came 270 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 Honeynaps Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253390?

K253390 is the FDA 510(k) for SOMNUM (SOMNUM), submitted by Honeynaps Co., Ltd.. FDA's decision date was Jun 27, 2026, under product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

Who makes the SOMNUM (SOMNUM)?

Honeynaps Co., Ltd., based in Seoul, is the applicant of record for K253390.

How long did the K253390 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jun 27, 2026, 270 days later.

← All decisions in June 2026