# K101867: Vicor PD2I Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Vicor Technologies, Inc.
- Decided: Apr 14, 2011 after 286 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: 5 generations back to K950779 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082709: Vicor PD2I Analyzer, Version 2.1, Vicor Technologies, Inc. (2008) Summary page 2.

## Indications for use
The Vicar PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV) at rest and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. The results are to be interpreted by a qualified healthcare practitioner. 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/K101867
Methodology: https://510kreport.com/methodology