510(k) · Cleared
ClearedBiomarc Preloaded Tissue Marker Device
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 Sep 20, 2004 as substantially equivalent to K023450 (Promex, Inc., 2002) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 2001. 2 of the 48 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.
- Decided
- Sep 20, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001807 (2001). 3 ancestors in all. 44 later devices descend from it, 4 citing it directly. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 1 generation backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- This deviceK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- Descendant · cites it directly · 25 of its ownK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 17 of its ownK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
- Descendant · cites it directly · 10 of its ownK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- Descendant · 3 generations on · 9 of its ownK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K063193Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006 · cites it directly25descendants
- K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007 · 2 generations on17descendants
- K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012 · cites it directly10descendants
- K072913Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008 · cites it directly10descendants
- K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −1 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| +1 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| +2 | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| +1 | K111895 | Echotip (R) Ultra Fiducial Needle | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
| +1 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| +3 | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 2 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K023450 | Biopsy Site Tissue Marker DeviceSummary page 1…Implantable Clip, 21 CFR 878.4300 Common/Usual Name: Tissue Marker Predicate Device Promex Biopsy Site Tissue Marker Device (k)023450 BiomarC Tissue Marker (k) 032347 Indication for Use BiomarC Preloaded Tissue Marker Device is indicated for use to radiographica… | 2002 |
| * | K032347 | Biomarc Tissue MarkerSummary page 1…lantable Clip, 21 CFR 878.4300 Common/Usual Name: Tissue Marker Predicate Device Promex Biopsy Site Tissue Marker Device (k)023450 BiomarC Tissue Marker (k) 032347 Indication for Use BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue during a sur… | 2003 |
What descends from it? (44)
See all 444 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063193 (Carbon Medical Technologies, Inc., 2006) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K023450.
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 Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042296: Biomarc Preloaded Tissue Marker Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042296
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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