# K133697: Breast-Med Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Breast-Med, Inc.
- Decided: Apr 10, 2015 after 493 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: 6 generations back to K001807 (2001). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032347: Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2003) Summary page 4.
- K093473: KMD-MARK1 Tissue Marker, Kent Medical Devices, Inc. (2010) Summary page 4.

## Most influential descendants
- K251989: VizMark Preloaded Tissue Marker Device (VM-0001) (2025), 0 descendants of its own

## Indications for use
The Breast-Med Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K133697
Methodology: https://510kreport.com/methodology