# K241762: OneMark

- Pathway: 510(k) (Traditional)
- Applicant: View Point Medical
- Decided: Sep 16, 2024 after 88 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: 1 generation back to K181007 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181007: Cianna Medical SAVI Scout Reflector and SAVI Scout System, Cianna Medical, Inc. (2018) Summary page 4.

## Indications for use
The OneMark Breast Localization Marker is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or soft tissue intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or detection imaging (OneMark Detection Imaging System), the OneMark Breast Localization Marker is located and may be surgically removed with the target tissue. The OneMark Detection Imaging System is intended only for the detection of the OneMark Breast Localization Marker.

Source page: https://510kreport.com/device/K241762
Methodology: https://510kreport.com/methodology