510(k) Report

510(k) · Cleared

Cleared

BiomarC Fiducial Marker

K191797510(k) SpecialCleared Jul 29, 201926-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carbon Medical Technologies · IYE Accelerator, Linear, Medical

Cleared on Jul 29, 2019 as substantially equivalent to K110772 (Carbon Medical Technologies, Inc., 2011) and 2 other predicates after a 26-day review. Its family tree reaches back 7 generations to 1995.

Decided
Jul 29, 2019
Review
26 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K935844 (1995). 19 ancestors in all, the oldest K934356 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2011: 1 other ancestor2013: 1 other ancestor2007: 2 other ancestors2006: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2003: 1 other ancestor2000: 1 other ancestor1994: 1 other ancestor2001: 1 other ancestorK935844 · Gip/Medi-Globe Needle System for Ultrasonic Fna · Medi-Globe Corp. · 1995K990220 · Modification of Gip/Medi-Globe Ultrasound Needle System · Medi-Globe Corp. · 1999K051247 · Sonotip II Ultrasound Needle System · Medi-Globe Corp. · 2005K070129 · Sonotip II Ultrasound Needle System · Medi-Globe Corporation · 2007K083330 · Echotip Ultra Ultrasound Needle · Cook Endoscopy · 2009K111895 · Echotip (R) Ultra Fiducial Needle · Wilson-Cook Medical Inc./Cook Endoscopy · 2012K132708 · Biomarc Fiducial Marker · Carbon Medical Technologies, Inc. · 20131990199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor K132708 · Biomarc Fiducial Marker · Carbon Medical Technologies, Inc. · 2013K111895 · Echotip (R) Ultra Fiducial Needle · Wilson-Cook Medical Inc./Cook Endoscopy · 2012K083330 · Echotip Ultra Ultrasound Needle · Cook Endoscopy · 2009K070129 · Sonotip II Ultrasound Needle System · Medi-Globe Corporation · 2007K051247 · Sonotip II Ultrasound Needle System · Medi-Globe Corp. · 2005K990220 · Modification of Gip/Medi-Globe Ultrasound Needle System · Medi-Globe Corp. · 1999K935844 · Gip/Medi-Globe Needle System for Ultrasonic Fna · Medi-Globe Corp. · 1995−50
  1. Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
  2. 6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
  3. 5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
  4. 4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
  5. 3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
  6. 2 generations backK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
  7. 1 generation backK132708 Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2013
  8. This deviceK191797 BiomarC Fiducial MarkerCarbon Medical Technologies · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K935844Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp.1995—
−6K990220Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp.1999—
−5K051247Sonotip II Ultrasound Needle SystemMedi-Globe Corp.2005—
−4K070129Sonotip II Ultrasound Needle SystemMedi-Globe Corporation2007—
−3K083330Echotip Ultra Ultrasound NeedleCook Endoscopy2009—
−2K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy2012—
−1K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.2013—
0 (this device)K191797BiomarC Fiducial MarkerCarbon Medical Technologies2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200010
200110
200210
200310
200410
200610
200720
201110
201310
201410
FIG. 1 — Lineage of K191797, 1995–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K110772Biomarc Fiducial Marker
Summary page 5
…ommon Name: Fiducial Marker Classification Name: Accelerator, Linear, Medical (21 CFR 892.5050, IYE) Predicate Device BiomarC Fiducial Marker (K110772) BiomarC Fiducial Marker (K132064) BiomarC Fiducial Marker (K132708) Indication for Use The BiomarC Fiducial Markers are intend…
Carbon Medical Technologies, Inc.2011—
*K132064Biomarc Fiducial Marker
Summary page 5
…ial Marker Classification Name: Accelerator, Linear, Medical (21 CFR 892.5050, IYE) Predicate Device BiomarC Fiducial Marker (K110772) BiomarC Fiducial Marker (K132064) BiomarC Fiducial Marker (K132708) Indication for Use The BiomarC Fiducial Markers are intended to be implanted into the body t…
Carbon Medical Technologies, Inc.20141
*K132708Biomarc Fiducial Marker
Summary page 5
…Accelerator, Linear, Medical (21 CFR 892.5050, IYE) Predicate Device BiomarC Fiducial Marker (K110772) BiomarC Fiducial Marker (K132064) BiomarC Fiducial Marker (K132708) Indication for Use The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constit…
Carbon Medical Technologies, Inc.2013—

Also cleared against K110772: 4 other devices →

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 24 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
  • 2 of the 19 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K110772.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K110772

4 other devices cite the same predicate.

  • K211590Fiducial MarkerCarbon Medical Technologies, Inc. · 2021
  • K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics · 2017
  • K132064Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 20141 recall
  • K130678Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc. · 2013

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K191797 · printed Nov 5, 2026

Cite this page

510(k) Report. “K191797: BiomarC 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/K191797

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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