510(k) · Cleared
ClearedBiopsy Site Tissue Marker Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promex, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Dec 19, 2002 after a 65-day review. The FDA summary names no predicate by number. 2 of the 46 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it.
- Decided
- Dec 19, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 2 citing it directly. 2 of the 46 devices in this family, counting this one, have a Class I recall.
- This deviceK023450 Biopsy Site Tissue Marker DevicePromex, Inc. · 2002
- Descendant · cites it directly · 44 of its ownK042296 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 · 2 generations on · 10 of its ownK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
- Descendant · 2 generations on · 10 of its ownK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 45 · See all- K042296Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004 · cites it directly44descendants
- 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 · 2 generations on10descendants
- K072913Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023450 | Biopsy Site Tissue Marker Device | Promex, Inc. | 2002 | — |
| +1 | 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 | — |
| +2 | K111895 | Echotip (R) Ultra Fiducial Needle | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
| +2 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (45)
See all 452 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?
- Of its descendants, K042296 (Carbon Medical Technologies, Inc., 2004) has gone furthest, with 44 descendants of its own.
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?
These devices are intended to be used to mark an open or percutaneous biopsy site to radiographically mark the location of the biopsy site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023450: Biopsy Site 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/K023450
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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