# K140835: General and Plastic Surgery

- Pathway: 510(k) (Special)
- Applicant: Scion Medical Technologies, LLC
- Decided: May 20, 2014 after 48 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001807 (2001). 13 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130763: Beacon Tissue Marker, Scion Medical Technologies, LLC (2013) Summary page 1.
- K093473: KMD-MARK1 Tissue Marker, Kent Medical Devices, Inc. (2010) Summary page 2.
- K063193: Modification to Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2006) Summary page 2.

## Most influential descendants
- K170026: Radiopaque Tissue Marker (2017), 0 descendants of its own
- K170905: Star Tissue Marker (2017), 0 descendants of its own
- K153189: Beacon Tissue Marker (SE) (2015), 0 descendants of its own

## Indications for use
The Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K140835
Methodology: https://510kreport.com/methodology