# K082782: Replication Medical Vessel Guard

- Pathway: 510(k) (Traditional)
- Applicant: Replication Medical, Inc.
- Decided: Apr 2, 2009 after 192 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). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061727: Gore Preclude Vessel Guard, W. L. Gore & Associates, Inc. (2006) Summary page 1.
- K960532: Preclude Ima Sleeve, W. L. Gore & Associates, Inc. (1996) Summary page 1.

## Most influential descendants
- K103558: Synthes Scout Vessel Guard (2011), 1 descendant of its own
- K111048: Synthes Scout Tack Fixation (2012), 0 descendants of its own
- K100984: Xylos Vessel Guard (2010), 0 descendants of its own

## Indications for use
The EnGuardTM Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.

Source page: https://510kreport.com/device/K082782
Methodology: https://510kreport.com/methodology