510(k) · Cleared
ClearedSecurmark Biopsy Site Marking 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 Oct 8, 2010 as substantially equivalent to K072913 (Suros Surgical Systems, Inc. A Hologic Company, 2008) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Oct 8, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001807 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- This deviceK102608 Securmark Biopsy Site Marking SystemSuros Surgical Systems, Inc. A Hologic Company · 2010
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 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| 0 (this device) | K102608 | Securmark Biopsy Site Marking System | Suros Surgical Systems, Inc. A Hologic Company | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072913 | Securmark Biopsy Site Identification SystemSummary page 1…andard: None established PREDICATE DEVICES: 510(k) Number Device Name Device Manufacturer Locat~ion K072913 SecurMark Biopsy Site Hologic, Inc. Indianapolis, IN Iden… | 2008 |
| * | K062528 | Tissue Site Marking SystemSummary page 2…ems The SecurMark Biopsy Site Marker that isthe subject of this submission is comprised of two 510(k) cleared devices. The first is an implantable component, covered by K062528, held by Hologic, Inc. which is composed of a bioabsorbable component and a permanent marking component (316 stainless steel or t… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K072913.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Biopsy 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/K102608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102608: Securmark Biopsy Site Marking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102608
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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