510(k) · Cleared
ClearedBiomarc Fiducial Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbon Medical Technologies, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Dec 20, 2013 as substantially equivalent to K063193 (Carbon Medical Technologies, Inc., 2006) and 1 other predicate after a 113-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935844 (1995). 13 ancestors in all, the oldest K934356 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 5 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 4 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 3 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 2 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 1 generation backK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
- This deviceK132708 Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK191797 BiomarC Fiducial MarkerCarbon Medical Technologies · 2019
- Descendant · cites it directly · 0 of its ownK171467 BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −5 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −4 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −3 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −2 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −1 | K111895 | Echotip (R) Ultra Fiducial Needle | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
| 0 (this device) | K132708 | Biomarc Fiducial Marker | Carbon Medical Technologies, Inc. | 2013 | — |
| +1 | K191797 | BiomarC Fiducial Marker | Carbon Medical Technologies | 2019 | — |
| +1 | K171467 | BioZorb Marker GOLD / LP Marker GOLD | Focal Therapeutics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K063193 | Modification to Biomarc Tissue MarkerSummary page 1…ducial Marker Common Name: Tissue Marker Classification Name: Implantable Clip (21 CFR 878.4300, NEU) Predicate Devices BiomarC Tissue Marker (K063 193) EchoTip® Ultra Fiducial Needle (KI 111895) Indication for Use The BiomarC Fiducial Marker is indicated for use to radiographic… | 2006 |
| * | K111895 | Echotip (R) Ultra Fiducial NeedleSummary page 1…issue Marker Classification Name: Implantable Clip (21 CFR 878.4300, NEU) Predicate Devices BiomarC Tissue Marker (K063 193) EchoTip® Ultra Fiducial Needle (KI 111895) Indication for Use The BiomarC Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical p… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K191797 (Carbon Medical Technologies, 2019) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K063193.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 BiomarC Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132708: 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/K132708
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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