# K924125: Cri Electronic Control System

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Research C/O Burditt, Bowles & Radzius
- Decided: May 26, 1993 after 282 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
No predicates in its family tree.
40 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath (2002), 39 descendants of its own
- K021555: Stereotaxis Niobe Magnetic Navigation System (2003), 35 descendants of its own
- K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath (2007), 27 descendants of its own
- K073225: Sensei Catheter Control System (2008), 24 descendants of its own
- K090365: Hansen Medical Artisan S Control Catheter (2009), 22 descendants of its own

Source page: https://510kreport.com/device/K924125
Methodology: https://510kreport.com/methodology