# K052295: Cardiosoft PC Ecg, Usb Version

- Pathway: 510(k) (Traditional)
- Applicant: Cardiosoft, L.P.
- Decided: Jan 13, 2006 after 143 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: 1 generation back to K924544 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924544: Cardiax, Fairlake Marketing Group, Inc. (1993) Summary page 1.

## Indications for use
The CardioSoft PC ECG is intended for use in acquiring, processing, recording, archiving and displaying electrocardiographic information. It can provide serial comparison of ECG information to facilitate review of current and previous records and is intended for use by trained operators. The system offers no diagnostic opinion to the user, but may be used by a physician to render his or her own medical opinion.

Source page: https://510kreport.com/device/K052295
Methodology: https://510kreport.com/methodology