# K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560

- Pathway: 510(k) (Traditional)
- Applicant: Somatex Medical Technologies GmbH
- Decided: Mar 19, 2008 after 139 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970817 (1997). 7 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376, Mri Devices Corp. (2004) Summary page 2.
- (no number) UltraClip Tissue Marker: named in the summary without a submission number

## Most influential descendants
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 (2010), 21 descendants of its own
- 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

## Recalls of this device
- May 22, 2017 · Class II · Z-0410-2018: There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.

## Indications for use
The Tumark®Professional is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.

Source page: https://510kreport.com/device/K073095
Methodology: https://510kreport.com/methodology