# K100984: Xylos Vessel Guard

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Jul 7, 2010 after 90 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: 13 generations back to K921895 (1992). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090778: Mta Protective Sheet, Xylos Corporation (2009) Summary page 1.
- K082782: Replication Medical Vessel Guard, Replication Medical, Inc. (2009) Summary page 1.
- K062161: Gore Propaten Vascular Graft, W. L. Gore & Associates, Inc. (2006) Summary page 1.
- K960532: Preclude Ima Sleeve, W. L. Gore & Associates, Inc. (1996) Summary page 1.

## Indications for use
XYLOS TM Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

Source page: https://510kreport.com/device/K100984
Methodology: https://510kreport.com/methodology