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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 / K260929

510(k) cleared

Neonav ECG Tip Location System

Navi Medical Technologies · Apr 17, 2026 · K260929

FDA cleared the Neonav ECG Tip Location System from Navi Medical Technologies on Apr 17, 2026 under K260929, a special 510(k). The device falls under product code LJS, Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, regulated at 21 CFR 880.5970 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 20, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Navi Medical Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260929?

K260929 is the FDA 510(k) for Neonav ECG Tip Location System, submitted by Navi Medical Technologies. FDA's decision date was Apr 17, 2026, under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).

Who makes the Neonav ECG Tip Location System?

Navi Medical Technologies, based in Carlton, is the applicant of record for K260929.

How long did the K260929 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Apr 17, 2026, 28 days later.

← All decisions in April 2026