# K110772: Biomarc Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Apr 28, 2011 after 38 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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). 6 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071614: Fiducial Markers, Civco (2007) Summary page 1.
- K063193: Modification to Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K130678: Biomarc Gold Fiducial Marker (2013), 2 descendants of its own
- K132064: Biomarc Fiducial Marker (2014), 1 descendant of its own
- K211590: Fiducial Marker (2021), 0 descendants of its own
- 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 Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Source page: https://510kreport.com/device/K110772
Methodology: https://510kreport.com/methodology