# K042566: Vasc-Alert

- Pathway: 510(k) (Traditional)
- Applicant: Vasc-Alert, Inc.
- Decided: Nov 8, 2004 after 48 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960817 (1997). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030456: Vasc-Alert, Vasc-Alert, LLC (2003) Summary page 1.

## Most influential descendants
- K093834: Crit-Line Anemia Management Software (2010), 3 descendants of its own
- K130579: Physoft Ams (2013), 2 descendants of its own
- K232283: PhySoftAMS® (2023), 0 descendants of its own
- K180410: Dosis SAM (2019), 0 descendants of its own

## Indications for use
Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a non-critical care setting for assessment of increased risk of access site stenosis in patients with grafts and fistulas, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines.

Source page: https://510kreport.com/device/K042566
Methodology: https://510kreport.com/methodology