# K131654: Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker

- Pathway: 510(k) (Special)
- Applicant: Senorx, Inc.
- Decided: Jun 27, 2013 after 21 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: 2 generations back to K031938 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081085: Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GS, Senorx, Inc. (2008) Summary page 1.

## Most influential descendants
- K153189: Beacon Tissue Marker (SE) (2015), 0 descendants of its own

## Indications for use
The Breast Tissue Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Source page: https://510kreport.com/device/K131654
Methodology: https://510kreport.com/methodology