# K201298: VX1

- Pathway: 510(k) (Traditional)
- Applicant: Volta Medical
- Decided: Sep 16, 2020 after 124 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001437 (2000). 16 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093566: Carto XP EP Navigation System, Version 10, Biosense Webster, Inc. (2010) Summary page 4.

## Most influential descendants
- K223516: VX1+ (2023), 4 descendants of its own
- K232616: Volta AF-Xplorer (2023), 2 descendants of its own
- K243812: Volta AF-Xplorer (2025), 1 descendant of its own
- K211546: Vektor Computational ECG Mapping System (vMap) (2021), 1 descendant of its own
- K252429: Vektor Computational ECG Mapping System (vMap®) (2025), 0 descendants of its own

## Indications for use
The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

Source page: https://510kreport.com/device/K201298
Methodology: https://510kreport.com/methodology