510(k) · Cleared
ClearedTumark Flex for Mammotome,Tumark Flex for Atec
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 Nov 8, 2011 as substantially equivalent to K073095 (Somatex Medical Technologies GmbH, 2008) and 1 other predicate after a 145-day review. Its family tree reaches back 5 generations to 1997. 16 later devices descend from it.
- Decided
- Nov 8, 2011
- Review
- 145 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970817 (1997). 9 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- 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 deviceK111692 Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
- Descendant · cites it directly · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- Descendant · 2 generations on · 13 of its ownK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- Descendant · 3 generations on · 12 of its ownK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- Descendant · 4 generations on · 5 of its ownK210600 MOLLIMolli Surgical, Inc. · 2021
- Descendant · 5 generations on · 4 of its ownK223107 MOLLI 2Molli Surgical, Inc. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · cites it directly15descendants
- K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016 · 2 generations on13descendants
- K163541Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017 · 3 generations on12descendants
- K210600MOLLIMolli Surgical, Inc. · 2021 · 4 generations on5descendants
- K223107MOLLI 2Molli Surgical, Inc. · 2023 · 5 generations on4descendants
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) | K111692 | Tumark Flex for Mammotome,Tumark Flex for Atec | Somatex Medical Technologies GmbH | 2011 | — |
| +1 | K120804 | Cianna Medical Tissue Marker and Delivery System | Cianna Medical | 2013 | — |
| +2 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 | — |
| +3 | K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 | — |
| +4 | K210600 | MOLLI | Molli Surgical, Inc. | 2021 | — |
| +5 | K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K073095 | Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Summary page 2…D-14513 Teltow /Germany Legally marketed (unmodified) device: The predicate device is the TUMARK® Professional Tissue Site Marking System, [K073095, March 19, 2008] and the TUMARKO Professional / MRI TUMARK® Professional Tissue Site Marking System, [K093064, February 17, 20 10… | 2008 |
| * | K093064 | Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Summary page 2…ce is the TUMARK® Professional Tissue Site Marking System, [K073095, March 19, 2008] and the TUMARKO Professional / MRI TUMARK® Professional Tissue Site Marking System, [K093064, February 17, 20 10] Device Description (new devices): The TUMARK® Flex is a sterile, single use, preloaded tissue site marking… | 2010 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K120804 (Cianna Medical, 2013) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K073095.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker.
The TUMARK® Flex 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/K111692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111692: Tumark Flex for Mammotome,Tumark Flex for Atec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111692
Report an extraction error
Are you the manufacturer?
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