510(k) · Cleared
Recalled · Class III · 2024Biomarc Fiducial Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbon Medical Technologies, Inc. · IYE Accelerator, Linear, Medical
Cleared on Feb 28, 2014 as substantially equivalent to K110772 (Carbon Medical Technologies, Inc., 2011) and 1 other predicate after a 240-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 28, 2014
- Review
- 240 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001807 (2001). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 5 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 4 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 3 generations backK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- 2 generations backK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- 1 generation backK130678 Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc. · 2013
- This deviceK132064 Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK191797 BiomarC Fiducial MarkerCarbon Medical Technologies · 2019
Most influential descendants
Showing 1 of 1 · See all- K191797BiomarC Fiducial MarkerCarbon Medical Technologies · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −5 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −4 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −3 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| −2 | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| −1 | K130678 | Biomarc Gold Fiducial Marker | Carbon Medical Technologies, Inc. | 2013 | — |
| 0 (this device) | K132064 | Biomarc Fiducial Marker | Carbon Medical Technologies, Inc. | 2014 | — |
| +1 | K191797 | BiomarC Fiducial Marker | Carbon Medical Technologies | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 IYE? 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? (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 |
|---|---|---|---|
| * | K110772 | Biomarc Fiducial Marker | 2011 |
| * | K130678 | Biomarc Gold Fiducial MarkerSummary page 1…ker Classification Name: Accelerator, Linear. Medical (21 CFR 892.5050. lYE) Predicate Device BiomarC Fidc[ial Marker (Kl 10772) BiomarC Gold Fidu[cial Marker (K 130678) Indication for Use The BiomarC FiduIcial Markers are intended to be implanted into the body to accurately visualize and consti… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191797 | BiomarC Fiducial Marker | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2024 | Class III | Z-3161-2024 | Employee error | This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K191797 (Carbon Medical Technologies, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K110772.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 BiomarC 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132064: Biomarc Fiducial Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132064
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