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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 / April 2026 / K254223

510(k) cleared

Next Generation 088 Catheter

Balt USA, LLC · Apr 16, 2026 · K254223

FDA cleared the Next Generation 088 Catheter from Balt USA, LLC on Apr 16, 2026 under K254223, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Balt USA, LLC has 5 other decisions in the tracker over the last 12 months: K260199 (SLIM Microcatheter), P250009 (SQUID Liquid Embolic Agent (LEA)), K254221 (Optima Coil System (OptiOne Coil System)), K252569 (Carrier XL Delivery Catheter).

Questions & Answers

What did FDA clear under K254223?

K254223 is the FDA 510(k) for Next Generation 088 Catheter, submitted by Balt USA, LLC. FDA's decision date was Apr 16, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Next Generation 088 Catheter?

Balt USA, LLC, based in Irvine, CA, is the applicant of record for K254223.

How long did the K254223 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Apr 16, 2026, 108 days later.

← All decisions in April 2026

Sources