# K072919: Vendys, Model 6000 B B/C

- Pathway: 510(k) (Special)
- Applicant: Endothelix, Inc.
- Decided: Nov 2, 2007 after 18 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands). It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during, and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.

Source page: https://510kreport.com/device/K072919
Methodology: https://510kreport.com/methodology