# K060980: Vendys Model 5000 B/BC

- Pathway: 510(k) (Traditional)
- Applicant: Endothelix, Inc.
- Decided: Aug 16, 2007 after 493 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
Longest line of descent: 3 generations back to K830592 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031556: Vivatherm Themperature Measurement System, Vivant Medical, Inc. (2003) Summary page 1.
- K961365: Endocare Electornic Thermometer System, Endocare, Inc. (1996) Summary page 1.
- K843381: Uri TX-100 Multichannel Thermocouple, Uri Therm-X, Inc. (1984) Summary page 1.
- K032519: Endo Pat 2000, Itamar Medical (2003) Summary page 1.

## Indications for use
The VENDYS Model 5000 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/K060980
Methodology: https://510kreport.com/methodology