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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 / June 2026 / K261119

510(k) cleared

NorthStar Mapping System (MAP01 or MAP01-01)

Imricor Medical Systems, Inc. · Jun 30, 2026 · K261119

FDA cleared the NorthStar Mapping System (MAP01 or MAP01-01) from Imricor Medical Systems, Inc. on Jun 30, 2026 under K261119, 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 Apr 3, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Imricor Medical Systems, Inc. has 2 other decisions in the tracker over the last 12 months: K252164 (NorthStar Mapping System), K252794 (Vision-MR Diagnostic Catheter).

Questions & Answers

What did FDA clear under K261119?

K261119 is the FDA 510(k) for NorthStar Mapping System (MAP01 or MAP01-01), submitted by Imricor Medical Systems, Inc.. FDA's decision date was Jun 30, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the NorthStar Mapping System (MAP01 or MAP01-01)?

Imricor Medical Systems, Inc., based in Burnsville, MN, is the applicant of record for K261119.

How long did the K261119 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Jun 30, 2026, 88 days later.

← All decisions in June 2026

Sources