K262744 is the FDA 510(k) clearance record for GenesisX RMN, a class II device, cleared for Stereotaxis, Inc. on 2026-08-27 under FDA product code DXX (System, Catheter Control, Steerable). As of 2026-09-10 , FDA records show no recalls naming K262744.
Clearance record Decision date 2026-08-27 Received 2026-08-03 (24 days to decision) Product code DXX System, Catheter Control, SteerableRegulation 21 CFR 870.1290 Device class Class II Review panel Cardiovascular Applicant Stereotaxis, Inc. 710 Tucker Blvd., Suite 110, St. Louis MO 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code DXX Trailing 12 months 2 clearances under product code DXX in the twelve months to October 2026, November 2025 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
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About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-12 . View this record on fda.gov ↗ (opens on fda.gov)
