510(k) · Cleared
ClearedC4 Fiducial Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C4 Imaging, LLC · NEU Marker, Radiographic, Implantable
Cleared on Oct 21, 2020 as substantially equivalent to K102506 (Cortex Manufacturing, Inc., 2011) and 1 other predicate after a 387-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Oct 21, 2020
- Review
- 387 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001807 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 3 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 2 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 1 generation backK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- This deviceK192771 C4 Fiducial MarkerC4 Imaging, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −3 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −2 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −1 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K192771 | C4 Fiducial Marker | C4 Imaging, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 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 |
|---|---|---|---|
| * | K102506 | Mixed Media MarkerSummary page 5…K192771 Page 2 of 3 Predicate Devices Mixed media marker K102506 Cortex Manufacturing BiomarC Fiducial Marker K063193 Carbon Medical… | 2011 |
| * | K063193 | Modification to Biomarc Tissue MarkerSummary page 5…Predicate Devices Mixed media marker K102506 Cortex Manufacturing BiomarC Fiducial Marker K063193 Carbon Medical Technologies Device Des… | 2006 |
| † | K171487 | Sirius MRI Marker NS | 2017 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 3 other devices also cite its predicate K102506.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 C4 Fiducial Marker is indicated 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 device can be visualized using MRI, CT or x-ray, and provides
a reference from which other procedures can be guided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192771: C4 Fiducial Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192771
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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