# K110358: Venodyne V810

- Pathway: 510(k) (Traditional)
- Applicant: Microtek Medical, Inc.
- Decided: May 5, 2011 after 87 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- 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 K953648 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040511: SCD Express Portable Compression System, Tyco Healthcare/Kendall (2004)
- K001802: Venodyne DVT Advantage Model 610, Microtek Medical, Inc. (2001) Summary page 1.
- K011318: Venodyne DVT Advantage Plus, Microtek Medical, Inc. (2001) Summary page 1.

## Indications for use
The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Vein Thrombosis) in patients at risk.

Source page: https://510kreport.com/device/K110358
Methodology: https://510kreport.com/methodology