# K252429: Vektor Computational ECG Mapping System (vMap®)

- Pathway: 510(k) (Traditional)
- Applicant: Vektor Medical, Inc.
- Decided: Dec 4, 2025 after 125 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: 20 generations back to K000248 (2000). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211546: Vektor Computational ECG Mapping System (vMap), Vektor Medical, Inc. (2021) Summary page 5.
- K223516: VX1+, Volta Medical (2023) Summary page 5.
- K242016: EnSite™ X EP System, Abbott Medical (2024) Summary page 5.

## Indications for use
The Vektor Computational ECG Mapping System (vMap®) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.

Source page: https://510kreport.com/device/K252429
Methodology: https://510kreport.com/methodology
