510(k) · Cleared
Recalled · Class II · 2017Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somatex Medical Technologies GmbH · NEU Marker, Radiographic, Implantable
Cleared on Mar 19, 2008 as substantially equivalent to K033447 (Mri Devices Corp., 2004) after a 139-day review. Its family tree reaches back 3 generations to 1997. 23 later devices descend from it. It has been recalled once.
- Decided
- Mar 19, 2008
- Review
- 139 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970817 (1997). 7 ancestors in all. 23 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- 2 generations backK993785 Ultraclip Tissue MarkerInrad · 2000 · Recalled
- 1 generation backK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
- This deviceK073095 Tumark Professional, Model 271560; MR- Tumark Professional, Model…Somatex Medical Technologies GmbH · 2008
- Descendant · cites it directly · 21 of its ownK093064 Tumark Professional, Model 271560, MR-Tumark Professional, Model…Somatex Medical Technologies GmbH · 2010
- Descendant · cites it directly · 16 of its ownK111692 Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
- Descendant · 2 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- Descendant · 3 generations on · 13 of its ownK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- Descendant · 4 generations on · 12 of its ownK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2010 · cites it directly21descendants
- K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011 · cites it directly16descendants
- K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 2 generations on15descendants
- K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016 · 3 generations on13descendants
- K163541Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| −2 | K993785 | Ultraclip Tissue Marker | Inrad | 2000 | 1 |
| −1 | K033447 | Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models… | Mri Devices Corp. | 2004 | — |
| 0 (this device) | K073095 | Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560 | Somatex Medical Technologies GmbH | 2008 | — |
| +1 | K093064 | Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 | Somatex Medical Technologies GmbH | 2010 | — |
| +1 | K111692 | Tumark Flex for Mammotome,Tumark Flex for Atec | Somatex Medical Technologies GmbH | 2011 | — |
| +2 | K120804 | Cianna Medical Tissue Marker and Delivery System | Cianna Medical | 2013 | — |
| +3 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 | — |
| +4 | K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NEU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033447 | Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Summary page 2…umark Professional is substantial equivalent to the Equivalence: ClipLoc Soft Tissue marker (the "ClipLoc") manufactured by MRI Devices Corporation (K033447) and the UltraClip Tissue Marker (the "UltraClip") manufactured by Irad Inc. The Turnark and ea… | 2004 |
| * | — | UltraClip Tissue Marker Named without a submission number |
What descends from it? (23)
See all 234 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093064 | Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 | 2010 | 21 |
| K111692 | Tumark Flex for Mammotome,Tumark Flex for Atec | 2011 | 16 |
| K232865 | Magseed Pro Magnetic Marker System | 2024 | 0 |
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2017 | Class II | Z-0410-2018 | Device Design | There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K093064 (Somatex Medical Technologies GmbH, 2010) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K033447.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073095
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026