# K024278: Paceart System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: May 29, 2003 after 157 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952065 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952065: Paceart Cardiovoice, Paceart, Inc. (1996) Summary page 2.

## Most influential descendants
- K110693: Paceart Optima System Software (2011), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Recalls of this device
- Aug 27, 2007 · Not classified · Z-0081-2008: An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST 
- Feb 2, 2006 · Not classified · Z-0911-06: The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of im

## Indications for use
The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.

Source page: https://510kreport.com/device/K024278
Methodology: https://510kreport.com/methodology