# K040313: HRV Tools

- Pathway: 510(k) (Traditional)
- Applicant: Del Mar Reynolds Medical, Ltd.
- Decided: Apr 6, 2004 after 57 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 K922171 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option, General Electric Medical Systems Information Techn (1999) Summary page 1.
- K021230: HERO, Medical Decision Networks (2003) Summary page 1.

## Indications for use
HRV Tools is indicated when it is desired to analyze the basic rhythms of the R-R intervals in electrocardiograms. It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses

Source page: https://510kreport.com/device/K040313
Methodology: https://510kreport.com/methodology