# K251989: VizMark Preloaded Tissue Marker Device (VM-0001)

- Pathway: 510(k) (Traditional)
- Applicant: Breast-Med, Inc.
- Decided: Dec 12, 2025 after 168 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: 7 generations back to K001807 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133697: Breast-Med Tissue Marker, Breast-Med, Inc. (2015) Summary page 5.
- K100994: Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2010) Summary page 6.

## Indications for use
The VizMark Preloaded 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/K251989
Methodology: https://510kreport.com/methodology