510(k) · Cleared
Recalled · 2008Fiducial Markers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civco · IYE Accelerator, Linear, Medical
Cleared on Sep 11, 2007 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 39 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 11, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 0
38 later devices descend from it, 11 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.
- This deviceK071614 Fiducial MarkersCivco · 2007
- Descendant · cites it directly · 25 of its ownK102506 Mixed Media MarkerCortex Manufacturing, Inc. · 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
- Descendant · cites it directly · 7 of its ownK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 38 · See all- K102506Mixed Media MarkerCortex Manufacturing, Inc. · 2011 · cites it directly25descendants
- 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
- K143484BioZorb MarkerFocal Therapeutics · 2015 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071614 | Fiducial Markers | Civco | 2007 | — |
| +1 | K102506 | Mixed Media Marker | Cortex Manufacturing, Inc. | 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 | — |
| +1 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 2 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (38)
See all 3811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102506 | Mixed Media Marker | 2011 | 25 |
| K143484 | BioZorb Marker Class I | 2015 | 7 |
| K110772 | Biomarc Fiducial Marker | 2011 | 5 |
| K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | 2014 | 2 |
| K130678 | Biomarc Gold Fiducial Marker | 2013 | 2 |
| K190155 | FibermarX Radiopaque Tissue Marker | 2019 | 0 |
| K180027 | ACCUSYTE 3D Fiducial Marker | 2018 | 0 |
| K171467 | BioZorb Marker GOLD / LP Marker GOLD | 2017 | 0 |
| K101131 | Fiducial Markers | 2010 | 0 |
| K092041 | Stellar Fiducial Marker, Model Gfmia | 2009 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2008 | Not classified | Z-1614-2008 | Labeling mix-ups | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers. |
| Feb 28, 2008 | Not classified | Z-1613-2008 | Labeling mix-ups | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers. |
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?
- Of its descendants, K102506 (Cortex Manufacturing, Inc., 2011) has gone furthest, with 25 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
Specifically, they can be use in intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K071614 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071614: Fiducial Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071614
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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