# K063193: Modification to Biomarc Tissue Marker

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Nov 21, 2006 after 32 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: 3 generations back to K001807 (2001). 4 ancestors in all.
25 later devices descend from it; 7 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042296: Biomarc Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2004) Summary page 1.
- K023450: Biopsy Site Tissue Marker Device, Promex, Inc. (2002) Summary page 1.

## Most influential descendants
- K070436: Biomarc Gold Tissue Marker (2007), 17 descendants of its own
- K093473: KMD-MARK1 Tissue Marker (2010), 9 descendants of its own
- K130763: Beacon Tissue Marker (2013), 5 descendants of its own
- K110772: Biomarc Fiducial Marker (2011), 5 descendants of its own
- K140835: General and Plastic Surgery (2014), 3 descendants of its own

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

Source page: https://510kreport.com/device/K063193
Methodology: https://510kreport.com/methodology