# K082709: Vicor PD2I Analyzer, Version 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Vicor Technologies, Inc.
- Decided: Dec 29, 2008 after 104 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: 4 generations back to K950779 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071168: The Portable Ansiscope, Dyansys, Inc. (2007) Summary page 2.

## Most influential descendants
- K101867: Vicor PD2I Analyzer (2011), 0 descendants of its own

## Indications for use
The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

Source page: https://510kreport.com/device/K082709
Methodology: https://510kreport.com/methodology