# K030456: Vasc-Alert

- Pathway: 510(k) (Traditional)
- Applicant: Vasc-Alert, LLC
- Decided: Jul 11, 2003 after 150 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- 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: 2 generations back to K960817 (1997). 3 ancestors in all.
5 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)
- K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2), Transonic Systems, Inc. (1997) Summary page 1.
- K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO, Transonic Systems, Inc. (1998) Summary page 1.
- K002372: Access Alert Gauge, Medisystems Corp. (2000) Summary page 1.

## Most influential descendants
- K042566: Vasc-Alert (2004), 4 descendants of its own
- 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, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.

Source page: https://510kreport.com/device/K030456
Methodology: https://510kreport.com/methodology