510(k) · Cleared
ClearedFiducial 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 Jun 10, 2021 as substantially equivalent to K110772 (Carbon Medical Technologies, Inc., 2011) and 1 other predicate after a 17-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 10, 2021
- Review
- 17 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001807 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 4 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 3 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 2 generations backK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- 1 generation backK100994 Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2010 · Recalled
- This deviceK211590 Fiducial MarkerCarbon Medical Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −4 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −3 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −2 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| −1 | K100994 | Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2010 | 1 |
| 0 (this device) | K211590 | Fiducial Marker | Carbon Medical Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 MarkerSummary page 4…Name: Medical charged-particle radiation therapy system 21 CFR 892.5050 Product Code: IYE Predicate Device BiomarC Fiducial Marker (K110772) Preloaded Tissue Marker (K100994) Indication for Use The [Trade Name] Fiducial Marker is intended to be implanted into the body… | 2011 |
| * | K100994 | Preloaded Tissue Marker DeviceSummary page 4…radiation therapy system 21 CFR 892.5050 Product Code: IYE Predicate Device BiomarC Fiducial Marker (K110772) Preloaded Tissue Marker (K100994) Indication for Use The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and consti… | 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 20 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 2021, 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 [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
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/K211590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211590: 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/K211590
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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