# K252500: CARA System

- Pathway: 510(k) (Traditional)
- Applicant: Cara Medical, Ltd.
- Decided: Feb 20, 2026 after 196 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913770 (1991). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212442: Cydar EV (Series B) and Cydar EV Maps, Cydar, Ltd. (2021) Summary page 5.

## Indications for use
The Cara System is intended for preplanning and guidance of medical interventions in an area known to contain or be adjacent to the cardiac conduction system, such as percutaneous or surgical procedures, for example, transcatheter aortic valve replacement (TAVR), as well as medical procedures where the physician desires to deliver therapy to the patient's cardiac conduction system or to a targeted location within it (CSP). The Cara System uses computed tomography angiography (CTA)-based and user manually marked landmarks to identify the cardiac conduction axis and generate a three-dimensional (3D) map of the individual patient’s cardiac conduction system. The system also overlays the anatomical location of the cardiac conduction system (generated by the Cara Metis Simulator using pre-procedure CT data) onto live fluoroscopic images. The software utilizes AI/ML algorithms to provide OCR detection, automated segmentation of anatomical structures, and detection of catheters. The CARA System is intended for use in adult patients (18 years of age and older).

Source page: https://510kreport.com/device/K252500
Methodology: https://510kreport.com/methodology