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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 / April 2026 / K252338

510(k) cleared

MySleepDash

Somnetics International, Inc. (Dba Transcend Inc) · Apr 17, 2026 · K252338

FDA cleared the MySleepDash from Somnetics International, Inc. (Dba Transcend Inc) on Apr 17, 2026 under K252338, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jul 28, 2025. The decision came 263 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 Somnetics International, Inc. (Dba Transcend Inc) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252338?

K252338 is the FDA 510(k) for MySleepDash, submitted by Somnetics International, Inc. (Dba Transcend Inc). FDA's decision date was Apr 17, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the MySleepDash?

Somnetics International, Inc. (Dba Transcend Inc), based in Fridley, MN, is the applicant of record for K252338.

How long did the K252338 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Apr 17, 2026, 263 days later.

← All decisions in April 2026