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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 / K253587

510(k) cleared

Cala kIQ Plus

Cala Health, Inc. · Mar 17, 2026 · K253587

FDA cleared the Cala kIQ Plus from Cala Health, Inc. on Mar 17, 2026 under K253587, a traditional 510(k). The device falls under product code QBC, External Upper Limb Tremor Stimulator, regulated at 21 CFR 882.5897 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 17, 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 Cala Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253587?

K253587 is the FDA 510(k) for Cala kIQ Plus, submitted by Cala Health, Inc.. FDA's decision date was Mar 17, 2026, under product code QBC (External Upper Limb Tremor Stimulator).

Who makes the Cala kIQ Plus?

Cala Health, Inc., based in San Mateo, CA, is the applicant of record for K253587.

How long did the K253587 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 17, 2026, 120 days later.

← All decisions in March 2026