# K201863: Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape

- Pathway: 510(k) (Traditional)
- Applicant: Somatex Medical Technologies GmbH
- Decided: Feb 18, 2021 after 227 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 K970817 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560, Somatex Medical Technologies GmbH (2008) Summary page 5.

## Indications for use
The Tumark@ Vision, the Tumark@ Professional, the Tumark@ Q and the Tumark@ Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.

Source page: https://510kreport.com/device/K201863
Methodology: https://510kreport.com/methodology