# K132708: Biomarc Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Dec 20, 2013 after 113 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: 6 generations back to K935844 (1995). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063193: Modification to Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2006) Summary page 1.
- K111895: Echotip (R) Ultra Fiducial Needle, Wilson-Cook Medical Inc./Cook Endoscopy (2012) Summary page 1.

## Most influential descendants
- K191797: BiomarC Fiducial Marker (2019), 0 descendants of its own
- K171467: BioZorb Marker GOLD / LP Marker GOLD (2017), 0 descendants of its own

## Indications for use
The BiomarC Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.

Source page: https://510kreport.com/device/K132708
Methodology: https://510kreport.com/methodology