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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 / K253176

510(k) cleared

TearView

Beyond 700 Pty, Ltd. · Jun 22, 2026 · K253176

FDA cleared the TearView from Beyond 700 Pty, Ltd. on Jun 22, 2026 under K253176, a traditional 510(k). The device falls under product code HKI, Camera, Ophthalmic, Ac-Powered, regulated at 21 CFR 886.1120 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Sep 26, 2025. The decision came 269 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 Beyond 700 Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253176?

K253176 is the FDA 510(k) for TearView, submitted by Beyond 700 Pty, Ltd.. FDA's decision date was Jun 22, 2026, under product code HKI (Camera, Ophthalmic, Ac-Powered).

Who makes the TearView?

Beyond 700 Pty, Ltd., based in Castle Hill, is the applicant of record for K253176.

How long did the K253176 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 22, 2026, 269 days later.

← All decisions in June 2026