510(k) · Cleared
ClearedTissue Site Marking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suros Surgical Systems, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Jan 26, 2007 after a 150-day review. The FDA summary names no predicate by number. 2 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Jan 26, 2007
- Review
- 150 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK062528 Tissue Site Marking SystemSuros Surgical Systems, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK072913 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
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K072913Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062528 | Tissue Site Marking System | Suros Surgical Systems, Inc. | 2007 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 124 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, K072913 (Suros Surgical Systems, Inc. A Hologic Company, 2008) has gone furthest, with 10 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. 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 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/K062528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062528: Tissue Site Marking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062528
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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