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The Tracker / August 2026 / K262744

510(k) cleared

GenesisX RMN

Stereotaxis, Inc. · Aug 27, 2026 · K262744

FDA cleared the GenesisX RMN from Stereotaxis, Inc. on Aug 27, 2026 under K262744, a special 510(k). The device falls under product code DXX, System, Catheter Control, Steerable, regulated at 21 CFR 870.1290 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 3, 2026. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

Stereotaxis, Inc. has 3 other decisions in the tracker over the last 12 months: K253473 (Synchrony), P240014 (MAGiC Ablation Catheter), K251792 (Stereotaxis GenesisX RMN with Navigant Workstation (NWS)).

Questions & Answers

What did FDA clear under K262744?

K262744 is the FDA 510(k) for GenesisX RMN, submitted by Stereotaxis, Inc.. FDA's decision date was Aug 27, 2026, under product code DXX (System, Catheter Control, Steerable).

Who makes the GenesisX RMN?

Stereotaxis, Inc., based in St. Louis, MO, is the applicant of record for K262744.

How long did the K262744 review take?

FDA received the submission on Aug 3, 2026 and issued its decision on Aug 27, 2026, 24 days later.

← All decisions in August 2026

Sources