# K012825: Hearttrends

- Pathway: 510(k) (Traditional)
- Applicant: Lev-El, Ltd.
- Decided: Mar 19, 2002 after 208 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K950944 (1996). 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)
- K950944: Ambulatory (Holter) Recording System, Biosensor Corp. (1996) Summary page 2.

## Indications for use
The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. It is also intended to provide measurements of the MPW (Multipole Paramater Weighted) HRV.

Source page: https://510kreport.com/device/K012825
Methodology: https://510kreport.com/methodology