# K262744: GenesisX RMN

- Pathway: 510(k) (Special)
- Applicant: Stereotaxis, Inc.
- Decided: Aug 27, 2026 after 24 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900765 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251792: Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS), Stereotaxis, Inc. (2025) Summary page 5.

## Indications for use
The GenesisX RMN is intended to navigate compatible magnetic devices in the chambers of the heart and arterial and venous vasculature by orienting the device tip in a desired direction.

Source page: https://510kreport.com/device/K262744
Methodology: https://510kreport.com/methodology