# K111692: Tumark Flex for Mammotome,Tumark Flex for Atec

- Pathway: 510(k) (Special)
- Applicant: Somatex Medical Technologies GmbH
- Decided: Nov 8, 2011 after 145 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: 5 generations back to K970817 (1997). 9 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 26 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 2.
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560, Somatex Medical Technologies GmbH (2010) Summary page 2.

## Most influential descendants
- K120804: Cianna Medical Tissue Marker and Delivery System (2013), 15 descendants of its own
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm (2016), 13 descendants of its own
- K163541: Magseed Magnetic Marker System (2017), 12 descendants of its own
- K210600: MOLLI (2021), 5 descendants of its own
- K223107: MOLLI 2 (2023), 4 descendants of its own

## Indications for use
The TUMARK® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker. The TUMARK® Flex is not indicated to be used with magnetic resonance imaging (MRI) techniques.

Source page: https://510kreport.com/device/K111692
Methodology: https://510kreport.com/methodology