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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 / September 2025 / K252700

510(k) cleared

Optima Coil System (Optima Packing Coil System)

Balt USA, LLC · Sep 26, 2025 · K252700

FDA cleared the Optima Coil System (Optima Packing Coil System) from Balt USA, LLC on Sep 26, 2025 under K252700, 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 Aug 27, 2025. The decision came 30 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)), K254221 (Optima Coil System (OptiOne Coil System)).

Questions & Answers

What did FDA clear under K252700?

K252700 is the FDA 510(k) for Optima Coil System (Optima Packing Coil System), submitted by Balt USA, LLC. FDA's decision date was Sep 26, 2025, under product code HCG (Device, Neurovascular Embolization).

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

Balt USA, LLC, based in Irvine, CA, is the applicant of record for K252700.

How long did the K252700 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Sep 26, 2025, 30 days later.

← All decisions in September 2025

Sources