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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 / April 2026 / K252455

510(k) cleared

FSYX Ocular Pressure Adjusting Pump

Balance Ophthalmics, Inc. · Apr 30, 2026 · K252455

FDA cleared the FSYX Ocular Pressure Adjusting Pump from Balance Ophthalmics, Inc. on Apr 30, 2026 under K252455, a traditional 510(k). The device falls under product code QQJ, Applicator, Negative Pressure, External, Ocular, regulated at 21 CFR 886.5000 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Aug 5, 2025. The decision came 268 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 Balance Ophthalmics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252455?

K252455 is the FDA 510(k) for FSYX Ocular Pressure Adjusting Pump, submitted by Balance Ophthalmics, Inc.. FDA's decision date was Apr 30, 2026, under product code QQJ (Applicator, Negative Pressure, External, Ocular).

Who makes the FSYX Ocular Pressure Adjusting Pump?

Balance Ophthalmics, Inc., based in Sioux Falls, SD, is the applicant of record for K252455.

How long did the K252455 review take?

FDA received the submission on Aug 5, 2025 and issued its decision on Apr 30, 2026, 268 days later.

← All decisions in April 2026