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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 / January 2026 / K253388

510(k) cleared

Sleepiz One+ (Model 2.5)

Sleepiz AG · Jan 28, 2026 · K253388

FDA cleared the Sleepiz One+ (Model 2.5) from Sleepiz AG on Jan 28, 2026 under K253388, a special 510(k). The device falls under product code DRT, Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 30, 2025. The decision came 120 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 Sleepiz AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253388?

K253388 is the FDA 510(k) for Sleepiz One+ (Model 2.5), submitted by Sleepiz AG. FDA's decision date was Jan 28, 2026, under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)).

Who makes the Sleepiz One+ (Model 2.5)?

Sleepiz AG, based in Zurich, is the applicant of record for K253388.

How long did the K253388 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 28, 2026, 120 days later.

← All decisions in January 2026