510(k) · Cleared
ClearedModification to Biomarc Tissue 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 Nov 21, 2006 as substantially equivalent to K042296 (Carbon Medical Technologies, Inc., 2004) and 1 other predicate after a 32-day review. Its family tree reaches back 3 generations to 2001. 25 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001807 (2001). 4 ancestors in all. 25 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 2 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 1 generation backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- This deviceK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK130763 Beacon Tissue MarkerScion Medical Technologies, LLC · 2013
- Descendant · cites it directly · 5 of its ownK110772 Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK140835 General and Plastic SurgeryScion Medical Technologies, LLC · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007 · cites it directly17descendants
- K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010 · 2 generations on9descendants
- K130763Beacon Tissue MarkerScion Medical Technologies, LLC · 2013 · cites it directly5descendants
- K110772Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2011 · cites it directly5descendants
- K140835General and Plastic SurgeryScion Medical Technologies, LLC · 2014 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −2 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −1 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| 0 (this device) | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| +1 | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| +2 | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
| +1 | K130763 | Beacon Tissue Marker | Scion Medical Technologies, LLC | 2013 | — |
| +1 | K110772 | Biomarc Fiducial Marker | Carbon Medical Technologies, Inc. | 2011 | — |
| +1 | K140835 | General and Plastic Surgery | Scion Medical Technologies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K042296 | Biomarc Preloaded Tissue Marker DeviceSummary page 1…e, 21 CFR 878.4750 Implantable Clip, 21 CFR 878.4300 Common/Usual Name: Tissue Marker Predicate Device BiomarC Tissue Marker (K042296) Promex Biopsy Site Tissue Marker Device (K023450) Indication for Use BiomarC Tissue Marker is indicated for use to radiograph… | 2004 |
| * | K023450 | Biopsy Site Tissue Marker DeviceSummary page 1…mplantable Clip, 21 CFR 878.4300 Common/Usual Name: Tissue Marker Predicate Device BiomarC Tissue Marker (K042296) Promex Biopsy Site Tissue Marker Device (K023450) Indication for Use BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedur… | 2002 |
What descends from it? (25)
See all 257 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 5 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070436 (Carbon Medical Technologies, Inc., 2007) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K042296.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063193: Modification to Biomarc Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063193
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