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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 / February 2026 / K252972

510(k) cleared

CARTO 3 EP Navigation System V8.4

Biosense Webster, Inc. · Feb 20, 2026 · K252972

FDA cleared the CARTO 3 EP Navigation System V8.4 from Biosense Webster, Inc. on Feb 20, 2026 under K252972, a traditional 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 Sep 17, 2025. The decision came 156 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Biosense Webster, Inc. has one other decision in the tracker over the last 12 months: K254085 (CARTO 3 EP Navigation System V9.0 with PIU Plus).

Questions & Answers

What did FDA clear under K252972?

K252972 is the FDA 510(k) for CARTO 3 EP Navigation System V8.4, submitted by Biosense Webster, Inc.. FDA's decision date was Feb 20, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the CARTO 3 EP Navigation System V8.4?

Biosense Webster, Inc., based in Irvine, CA, is the applicant of record for K252972.

How long did the K252972 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Feb 20, 2026, 156 days later.

← All decisions in February 2026

Sources