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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 / December 2025 / K252348

510(k) cleared

Tomey Optical Biometer OA-2000 (OA-2000)

Tomey Corporation · Dec 18, 2025 · K252348

FDA cleared the Tomey Optical Biometer OA-2000 (OA-2000) from Tomey Corporation on Dec 18, 2025 under K252348, a traditional 510(k). The device falls under product code MXK, Device, Analysis, Anterior Segment, regulated at 21 CFR 886.1850 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jul 29, 2025. The decision came 142 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 Tomey Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252348?

K252348 is the FDA 510(k) for Tomey Optical Biometer OA-2000 (OA-2000), submitted by Tomey Corporation. FDA's decision date was Dec 18, 2025, under product code MXK (Device, Analysis, Anterior Segment).

Who makes the Tomey Optical Biometer OA-2000 (OA-2000)?

Tomey Corporation, based in Nagoya, is the applicant of record for K252348.

How long did the K252348 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Dec 18, 2025, 142 days later.

← All decisions in December 2025