510(k) · Cleared
ClearedBiomarc Gold 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 Mar 16, 2007 as substantially equivalent to K063193 (Carbon Medical Technologies, Inc., 2006) after a 29-day review. Its family tree reaches back 4 generations to 2001. 17 later devices descend from it.
- Decided
- Mar 16, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001807 (2001). 5 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- 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 deviceK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK130763 Beacon Tissue MarkerScion Medical Technologies, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK140835 General and Plastic SurgeryScion Medical Technologies, LLC · 2014
- Descendant · cites it directly · 2 of its ownK173587 Magseed Magnetic Marker SysttemEndomagnetics Ltd., · 2018
- Descendant · cites it directly · 2 of its ownK130678 Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc. · 2013
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010 · cites it directly9descendants
- K130763Beacon Tissue MarkerScion Medical Technologies, LLC · 2013 · 2 generations on5descendants
- K140835General and Plastic SurgeryScion Medical Technologies, LLC · 2014 · 2 generations on3descendants
- K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd., · 2018 · cites it directly2descendants
- K130678Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc. · 2013 · cites it directly2descendants
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) | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| +1 | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
| +2 | K130763 | Beacon Tissue Marker | Scion Medical Technologies, LLC | 2013 | — |
| +2 | K140835 | General and Plastic Surgery | Scion Medical Technologies, LLC | 2014 | — |
| +1 | K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | 2018 | — |
| +1 | K130678 | Biomarc Gold Fiducial Marker | Carbon Medical Technologies, Inc. | 2013 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063193 | Modification to Biomarc Tissue MarkerSummary page 1…d Tissue Marker Classification Name: Implantable Clip, 21 CFR 878.4300 Common/Usual Name: Tissue Marker Predicate Device BiomarC Tissue Marker (K0063193) RadioMed Soft Tissue Marker (K022346) Indication for Use BiomarC Gold Tissue Marker is indicated for use to radiographically… | 2006 |
| Kept off the family tree | K022346 | FDA’s K022346 is Cleantexx Mint Flavour Blue Colour Powder-Free Barrier Pro Copolymer… Our reading of the summary gave K022346, FDA’s number for Cleantexx Mint Flavour Blue Colour Powder-Free Barrier Pro… (Latexx Manufacturing Sdn.Bhd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “RadioMed Soft Tissue Marker”. Kept off the family tree. Summary page 1…Implantable Clip, 21 CFR 878.4300 Common/Usual Name: Tissue Marker Predicate Device BiomarC Tissue Marker (K0063193) RadioMed Soft Tissue Marker (K022346) Indication for Use BiomarC Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical pro… | 2002 |
What descends from it? (17)
See all 174 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 6 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093473 (Kent Medical Devices, Inc., 2010) has gone furthest, with 9 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. 2007, 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 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/K070436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070436: Biomarc Gold Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070436
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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