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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 / May 2026 / K254133

510(k) cleared

ENTity USB Videoscope System

Optim, LLC · May 14, 2026 · K254133

FDA cleared the ENTity USB Videoscope System from Optim, LLC on May 14, 2026 under K254133, a traditional 510(k). The device falls under product code EOB, Nasopharyngoscope (Flexible Or Rigid), regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Dec 22, 2025. The decision came 143 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 Optim, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254133?

K254133 is the FDA 510(k) for ENTity USB Videoscope System, submitted by Optim, LLC. FDA's decision date was May 14, 2026, under product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Who makes the ENTity USB Videoscope System?

Optim, LLC, based in Sturbridge, MA, is the applicant of record for K254133.

How long did the K254133 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 14, 2026, 143 days later.

← All decisions in May 2026