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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 / July 2026 / K260588

510(k) cleared

Cleerly LABS

Cleerly, Inc. · Jul 29, 2026 · K260588

FDA cleared the Cleerly LABS from Cleerly, Inc. on Jul 29, 2026 under K260588, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 20, 2026. The decision came 159 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cleerly, Inc. has one other decision in the tracker over the last 12 months: K261210 (Cleerly Plaque).

Questions & Answers

What did FDA clear under K260588?

K260588 is the FDA 510(k) for Cleerly LABS, submitted by Cleerly, Inc.. FDA's decision date was Jul 29, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Cleerly LABS?

Cleerly, Inc., based in Denver, CO, is the applicant of record for K260588.

How long did the K260588 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Jul 29, 2026, 159 days later.

← All decisions in July 2026

Sources