# K211590: Fiducial Marker

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Jun 10, 2021 after 17 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: 5 generations back to K001807 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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) Summary page 4.
- K100994: Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2010) Summary page 4.

## Indications for use
The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

Source page: https://510kreport.com/device/K211590
Methodology: https://510kreport.com/methodology