510(k) · Cleared
ClearedSecurmark Biopsy Site Identification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suros Surgical Systems, Inc. A Hologic Company · NEU Marker, Radiographic, Implantable
Cleared on Jan 4, 2008 as substantially equivalent to K062528 (Suros Surgical Systems, Inc., 2007) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 2001. 2 of the 16 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Jan 4, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001807 (2001). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- 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 deviceK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- Descendant · cites it directly · 8 of its ownK113202 Tissue MarkerFocal Therapeutics · 2012
- Descendant · 2 generations on · 7 of its ownK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK152070 BioZorb LP MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK180640 SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK233639 SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K113202Tissue MarkerFocal Therapeutics · 2012 · cites it directly8descendants
- K143484BioZorb MarkerFocal Therapeutics · 2015 · 2 generations on7descendants
- K152070BioZorb LP MarkerFocal Therapeutics · 2015 · 3 generations on5descendants
- K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018 · 3 generations on1descendant
- K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024 · 4 generations on0descendants
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) | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| +1 | K113202 | Tissue Marker | Focal Therapeutics | 2012 | — |
| +2 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
| +3 | K152070 | BioZorb LP Marker | Focal Therapeutics | 2015 | Class I |
| +3 | K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | 2018 | — |
| +4 | K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 2 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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.
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 |
|---|---|---|---|
| * | K062528 | Tissue Site Marking SystemSummary page 1…No applicable performance standards established PREDICATE DEVICES: 510(k)-Number Device Name Device Manufacturer Location K062528 Tissue Site Marking Hologic, Inc. - Suros Division Indianapolis, IN System K0… | 2007 |
| * | K042296 | Biomarc Preloaded Tissue Marker DeviceSummary page 1…rer Location K062528 Tissue Site Marking Hologic, Inc. - Suros Division Indianapolis, IN System K042296 BiomarC Carbon Medical St. Paul, MN… | 2004 |
What descends from it? (10)
2 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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K113202 (Focal Therapeutics, 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K062528.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 SeCurMark Tissue Site Marking System is indicated for the permanent radiographic
marking of sites in soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072913: Securmark Biopsy Site Identification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072913
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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