WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / January 2026 / K253291

510(k) cleared

Excelsior System

Blue Ocean Global · Jan 20, 2026 · K253291

FDA cleared the Excelsior System from Blue Ocean Global on Jan 20, 2026 under K253291, a traditional 510(k). The device falls under product code KTT, Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 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 Blue Ocean Global in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253291?

K253291 is the FDA 510(k) for Excelsior System, submitted by Blue Ocean Global. FDA's decision date was Jan 20, 2026, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the Excelsior System?

Blue Ocean Global, based in Miami, FL, is the applicant of record for K253291.

How long did the K253291 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 20, 2026, 113 days later.

← All decisions in January 2026