510(k) · Cleared
ClearedTumark for Eviva, Tumark for Brevera
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 Oct 31, 2018 as substantially equivalent to K093064 (Somatex Medical Technologies GmbH, 2010) after a 90-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Oct 31, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970817 (1997). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- 4 generations backK993785 Ultraclip Tissue MarkerInrad · 2000 · Recalled
- 3 generations backK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
- 2 generations backK073095 Tumark Professional, Model 271560; MR- Tumark Professional, Model…Somatex Medical Technologies GmbH · 2008 · Recalled
- 1 generation backK093064 Tumark Professional, Model 271560, MR-Tumark Professional, Model…Somatex Medical Technologies GmbH · 2010
- This deviceK182082 Tumark for Eviva, Tumark for BreveraSomatex Medical Technologies GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| −4 | K993785 | Ultraclip Tissue Marker | Inrad | 2000 | 1 |
| −3 | K033447 | Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models… | Mri Devices Corp. | 2004 | — |
| −2 | K073095 | Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560 | Somatex Medical Technologies GmbH | 2008 | 1 |
| −1 | K093064 | Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 | Somatex Medical Technologies GmbH | 2010 | — |
| 0 (this device) | K182082 | Tumark for Eviva, Tumark for Brevera | Somatex Medical Technologies GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 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? (1)
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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K093064.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182082: Tumark for Eviva, Tumark for Brevera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182082
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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