510(k) · Cleared
ClearedMixed Media Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex Manufacturing, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Jan 12, 2011 as substantially equivalent to K071614 (Civco, 2007) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 2007. 2 of the 28 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it.
- Decided
- Jan 12, 2011
- Review
- 133 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K071614 (2007). 2 ancestors in all. 25 later devices descend from it, 4 citing it directly. 2 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK071614 Fiducial MarkersCivco · 2007 · Recalled
- This deviceK102506 Mixed Media MarkerCortex Manufacturing, Inc. · 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 · cites it directly · 7 of its ownK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- Descendant · 4 generations on · 5 of its ownK210600 MOLLIMolli Surgical, Inc. · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 25 · 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
- K143484BioZorb MarkerFocal Therapeutics · 2015 · cites it directly7descendants
- K210600MOLLIMolli Surgical, Inc. · 2021 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071614 | Fiducial Markers | Civco | 2007 | 2 |
| 0 (this device) | K102506 | Mixed Media Marker | Cortex Manufacturing, Inc. | 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 | — |
| +1 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
| +4 | K210600 | MOLLI | Molli Surgical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 2 | 2 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K071614 | Fiducial MarkersSummary page 1…me: Mixed Media Marker Product Code: NEU Common Name: Implanted Marker Classification: 878.4300 Class: 11 SE Devices: (K071614) Trade name: Implanted Fidlucial CIVCO Medical Solutions (IK100267) Trade name: FlexiMarc Cortex M… | 2007 |
| * | K100267 | Fleximarc, Model CM-0.9-2-10-GG-LSummary page 1…Implanted Marker Classification: 878.4300 Class: 11 SE Devices: (K071614) Trade name: Implanted Fidlucial CIVCO Medical Solutions (IK100267) Trade name: FlexiMarc Cortex Manufacturing Inc. Device Description: These implanted markers are used to i… | 2010 |
What descends from it? (25)
See all 254 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
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 Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices; the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102506: Mixed Media Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102506
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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