# K101805: Hydrofix Vaso Shield

- Pathway: 510(k) (Traditional)
- Applicant: Mimedx Group, Inc.
- Decided: Apr 8, 2011 after 284 days
- Product code: OMR (Vessel Guard Or Cover)
- Device class: 2
- Regulation: 21 CFR 870.3470
- 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 K811841 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090022: Paradis Vaso Shield, Spinemedica, LLC (2009) Summary page 1.
- K093551: Paradis Vaso Shield, Spinemedica, LLC (2009) Summary page 1.
- K100905: Hydrofix Surgical Sheet, Mimedx Group, Inc. (2010) Summary page 2.
- K061727: Gore Preclude Vessel Guard, W. L. Gore & Associates, Inc. (2006) Summary page 2.

## Indications for use
The HydroFix Vaso ShieldTM is indicated for use as a cover for vessels following anterior vertebral surgery.

Source page: https://510kreport.com/device/K101805
Methodology: https://510kreport.com/methodology