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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 / June 2026 / K254086

510(k) cleared

EyeBOX SNAP

Oculogica, Inc. · Jun 5, 2026 · K254086

FDA cleared the EyeBOX SNAP from Oculogica, Inc. on Jun 5, 2026 under K254086, a traditional 510(k). The device falls under product code QEA, Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid, regulated at 21 CFR 882.1455 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 18, 2025. The decision came 169 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 Oculogica, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254086?

K254086 is the FDA 510(k) for EyeBOX SNAP, submitted by Oculogica, Inc.. FDA's decision date was Jun 5, 2026, under product code QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid).

Who makes the EyeBOX SNAP?

Oculogica, Inc., based in New Richmond, WI, is the applicant of record for K254086.

How long did the K254086 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Jun 5, 2026, 169 days later.

← All decisions in June 2026