510(k) · Cleared
ClearedTumark Vision
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 22, 2018 as substantially equivalent to K093064 (Somatex Medical Technologies GmbH, 2010) after a 30-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 22, 2018
- Review
- 30 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 deviceK180443 Tumark VisionSomatex 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) | K180443 | Tumark Vision | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093064 | Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Summary page 5…SOMATEX Medical Tumark Vision Tumark Professional K093064 Technologies GmbH 4 Device Des… | 2010 |
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?
The Tumark Vision 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 intended 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/K180443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180443: Tumark Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180443
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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