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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 / February 2026 / K252500

510(k) cleared

CARA System

Cara Medical, Ltd. · Feb 20, 2026 · K252500

FDA cleared the CARA System from Cara Medical, Ltd. on Feb 20, 2026 under K252500, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 8, 2025. The decision came 196 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 Cara Medical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252500?

K252500 is the FDA 510(k) for CARA System, submitted by Cara Medical, Ltd.. FDA's decision date was Feb 20, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the CARA System?

Cara Medical, Ltd., based in Rd. Town, is the applicant of record for K252500.

How long did the K252500 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Feb 20, 2026, 196 days later.

← All decisions in February 2026