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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 / August 2026 / K253468

510(k) cleared

Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)

Nova Eye, Inc. · Aug 10, 2026 · K253468

FDA cleared the Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) from Nova Eye, Inc. on Aug 10, 2026 under K253468, a traditional 510(k). The device falls under product code MPA, Endoilluminator, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Oct 9, 2025. The decision came 305 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 Nova Eye, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253468?

K253468 is the FDA 510(k) for Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A), submitted by Nova Eye, Inc.. FDA's decision date was Aug 10, 2026, under product code MPA (Endoilluminator).

Who makes the Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)?

Nova Eye, Inc., based in Fremont, CA, is the applicant of record for K253468.

How long did the K253468 review take?

FDA received the submission on Oct 9, 2025 and issued its decision on Aug 10, 2026, 305 days later.

← All decisions in August 2026