# K103693: Vantage Abi

- Pathway: 510(k) (Traditional)
- Applicant: Summit Doppler Systems, Inc.
- Decided: Feb 15, 2011 after 60 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973644 (1997). 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)
- K042616: Biomedix Padnet Lab, Biomedix, Inc. (2004) Summary page 1.
- K063600: Vista Avs, Summit Doppler Systems, Inc. (2006) Summary page 1.

## Indications for use
The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.

Source page: https://510kreport.com/device/K103693
Methodology: https://510kreport.com/methodology