# K082312: Prime Ecg System (with Enhanced Diagnostic Algorithm)

- Pathway: 510(k) (Traditional)
- Applicant: Heartscape Technologies, Ltd.
- Decided: Sep 12, 2008 after 30 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: 3 generations back to K911139 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012414: Prime Ecg System, Meridian Medical Technologies, Inc. (2002) Summary page 1.
- K030104: Prime Ecg System, Meridian Medical Technologies, Inc. (2003) Summary page 1.

## Indications for use
The PRIME ECG ® with enhanced Diagnostic Algorithm system is intended for the recording of electrocardiographic signals from the body surface

Source page: https://510kreport.com/device/K082312
Methodology: https://510kreport.com/methodology