# K030104: Prime Ecg System

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Medical Technologies, Inc.
- Decided: Jun 11, 2003 after 149 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911139 (1991). 2 ancestors in all.
1 later device descends 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)
- K911139: Hewlett-Packard Models M1400A, M1402A & M1401A, Hewlett-Packard Co. (1991) Summary page 1.
- K012414: Prime Ecg System, Meridian Medical Technologies, Inc. (2002) Summary page 1.

## Most influential descendants
- K082312: Prime Ecg System (with Enhanced Diagnostic Algorithm) (2008), 0 descendants of its own

## Indications for use
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.

Source page: https://510kreport.com/device/K030104
Methodology: https://510kreport.com/methodology