# K042296: Biomarc Preloaded Tissue Marker Device

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Sep 20, 2004 after 27 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: 2 generations back to K001807 (2001). 3 ancestors in all.
44 later devices descend from it; 4 cite it directly.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023450: Biopsy Site Tissue Marker Device, Promex, Inc. (2002) Summary page 1.
- K032347: Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K063193: Modification to Biomarc Tissue Marker (2006), 25 descendants of its own
- K070436: Biomarc Gold Tissue Marker (2007), 17 descendants of its own
- K111895: Echotip (R) Ultra Fiducial Needle (2012), 10 descendants of its own
- K072913: Securmark Biopsy Site Identification System (2008), 10 descendants of its own
- K093473: KMD-MARK1 Tissue Marker (2010), 9 descendants of its own

## Indications for use
The BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K042296
Methodology: https://510kreport.com/methodology