# K142969: ANI Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mdoloris Medical Systems Sas
- Decided: Feb 23, 2016 after 497 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.
No later device cites it as a predicate yet.
0 of 11 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 4.

## Indications for use
The Mdoloris Medical Systems SAS HFVI Monitor is intended to acquire, 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/K142969
Methodology: https://510kreport.com/methodology