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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 / K254085

510(k) cleared

CARTO 3 EP Navigation System V9.0 with PIU Plus

Biosense Webster, Inc. · Jan 18, 2026 · K254085

FDA cleared the CARTO 3 EP Navigation System V9.0 with PIU Plus from Biosense Webster, Inc. on Jan 18, 2026 under K254085, a special 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 18, 2025. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

Biosense Webster, Inc. has one other decision in the tracker over the last 12 months: K252972 (CARTO 3 EP Navigation System V8.4).

Questions & Answers

What did FDA clear under K254085?

K254085 is the FDA 510(k) for CARTO 3 EP Navigation System V9.0 with PIU Plus, submitted by Biosense Webster, Inc.. FDA's decision date was Jan 18, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the CARTO 3 EP Navigation System V9.0 with PIU Plus?

Biosense Webster, Inc., based in Irvine, CA, is the applicant of record for K254085.

How long did the K254085 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Jan 18, 2026, 31 days later.

← All decisions in January 2026

Sources