# K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560

- Pathway: 510(k) (Traditional)
- Applicant: Somatex Medical Technologies GmbH
- Decided: Feb 17, 2010 after 140 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.
21 later devices descend from it; 4 cite it directly.
0 of 30 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 3.
- K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376, Mri Devices Corp. (2004) Summary page 3.
- (no number) UltraClip Tissue Marker: named in the summary without a submission number

## Most influential descendants
- K111692: Tumark Flex for Mammotome,Tumark Flex for Atec (2011), 16 descendants of its own
- 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

## Indications for use
The Tumark® Professional and MRI Tumark® Professional are intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. Only the MRI Tumark® Professional is indicated to be used in Magnetic Resonance Imaging (MRI) procedures.

Source page: https://510kreport.com/device/K093064
Methodology: https://510kreport.com/methodology