# K132064: Biomarc Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Feb 28, 2014 after 240 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001807 (2001). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110772: Biomarc Fiducial Marker, Carbon Medical Technologies, Inc. (2011)
- K130678: Biomarc Gold Fiducial Marker, Carbon Medical Technologies, Inc. (2013) Summary page 1.

## Most influential descendants
- K191797: BiomarC Fiducial Marker (2019), 0 descendants of its own

## Recalls of this device
- Jul 26, 2024 · Class III · Z-3161-2024: This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

## 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/K132064
Methodology: https://510kreport.com/methodology