# K190689: SignalMark Breast Marker

- Pathway: 510(k) (Traditional)
- Applicant: View Point Medical, Inc.
- Decided: Aug 14, 2019 after 149 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: 4 generations back to K023694 (2003). 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)
- K060769: Hydromark Biopsy Site Marker, Biopsy Sciences, LLC (2006) Summary page 5.

## Indications for use
The SignalMark Breast Marker is intended to provide accuracy in marking a surigcal site and/or a biopsy location for visualization during surgical resection.

Source page: https://510kreport.com/device/K190689
Methodology: https://510kreport.com/methodology