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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 / K252164

510(k) cleared

NorthStar Mapping System

Imricor Medical Systems · Jan 28, 2026 · K252164

FDA cleared the NorthStar Mapping System from Imricor Medical Systems on Jan 28, 2026 under K252164, 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 Jul 10, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Imricor Medical Systems has 2 other decisions in the tracker over the last 12 months: K261119 (NorthStar Mapping System (MAP01 or MAP01-01)), K252794 (Vision-MR Diagnostic Catheter).

Questions & Answers

What did FDA clear under K252164?

K252164 is the FDA 510(k) for NorthStar Mapping System, submitted by Imricor Medical Systems. FDA's decision date was Jan 28, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the NorthStar Mapping System?

Imricor Medical Systems, based in Burnsville, MN, is the applicant of record for K252164.

How long did the K252164 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Jan 28, 2026, 202 days later.

← All decisions in January 2026

Sources