# K070436: Biomarc Gold Tissue Marker

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Mar 16, 2007 after 29 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: 4 generations back to K001807 (2001). 5 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 23 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.

## Cited in the summary but kept off the family tree
- K022346: Cleantexx Mint Flavour Blue Colour Powder-Free Barrier Pro Copolymer Examination Gloves, Latexx Manufacturing Sdn.Bhd. (2002). Our reading of the summary gave K022346, FDA’s number for Cleantexx Mint Flavour Blue Colour Powder-Free Barrier Pro… (Latexx Manufacturing Sdn.Bhd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “RadioMed Soft Tissue Marker”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K093473: KMD-MARK1 Tissue Marker (2010), 9 descendants of its own
- K130763: Beacon Tissue Marker (2013), 5 descendants of its own
- K140835: General and Plastic Surgery (2014), 3 descendants of its own
- K173587: Magseed Magnetic Marker Systtem (2018), 2 descendants of its own
- K130678: Biomarc Gold Fiducial Marker (2013), 2 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/K070436
Methodology: https://510kreport.com/methodology