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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 / January 2026 / K254221

510(k) cleared

Optima Coil System (OptiOne Coil System)

Balt USA, LLC · Jan 27, 2026 · K254221

FDA cleared the Optima Coil System (OptiOne Coil System) from Balt USA, LLC on Jan 27, 2026 under K254221, a special 510(k). The device falls under product code HCG, Device, Neurovascular Embolization, regulated at 21 CFR 882.5950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 29, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Balt USA, LLC has 5 other decisions in the tracker over the last 12 months: K260199 (SLIM Microcatheter), K254223 (Next Generation 088 Catheter), P250009 (SQUID Liquid Embolic Agent (LEA)), K252569 (Carrier XL Delivery Catheter).

Questions & Answers

What did FDA clear under K254221?

K254221 is the FDA 510(k) for Optima Coil System (OptiOne Coil System), submitted by Balt USA, LLC. FDA's decision date was Jan 27, 2026, under product code HCG (Device, Neurovascular Embolization).

Who makes the Optima Coil System (OptiOne Coil System)?

Balt USA, LLC, based in Irvine, CA, is the applicant of record for K254221.

How long did the K254221 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Jan 27, 2026, 29 days later.

← All decisions in January 2026

Sources