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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 / October 2025 / K251876

510(k) cleared

cleadew GP hydra one

Ophtecs Corporation · Oct 9, 2025 · K251876

FDA cleared the cleadew GP hydra one from Ophtecs Corporation on Oct 9, 2025 under K251876, a traditional 510(k). The device falls under product code MRC, Products, Contact Lens Care, Rigid Gas Permeable, regulated at 21 CFR 886.5918 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jun 18, 2025. The decision came 113 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 Ophtecs Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251876?

K251876 is the FDA 510(k) for cleadew GP hydra one, submitted by Ophtecs Corporation. FDA's decision date was Oct 9, 2025, under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable).

Who makes the cleadew GP hydra one?

Ophtecs Corporation, based in Kobe, is the applicant of record for K251876.

How long did the K251876 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Oct 9, 2025, 113 days later.

← All decisions in October 2025