# K251748: MammoSTAR Biopsy Site Identifier

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Jul 23, 2025 after 47 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: 5 generations back to K001807 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100994: Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2010) Summary page 5.

## Indications for use
MammoSTAR Biopsy Site Identifier 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/K251748
Methodology: https://510kreport.com/methodology