# K032926: Ekg Speaks

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Oct 15, 2003 after 23 days
- Product code: KRE (Analyzer, Pacemaker Generator Function, Indirect)
- Device class: 2
- Regulation: 21 CFR 870.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG monitor. It also acts as a database for pacemaker and implantable cardioverter defibrillator patients.

Source page: https://510kreport.com/device/K032926
Methodology: https://510kreport.com/methodology