510(k) · Cleared
ClearedGel Mark Iii Biopsy Site Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senorx, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Sep 5, 2003 after a 74-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 5, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK031938 Gel Mark Iii Biopsy Site MarkerSenorx, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK081085 Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR…Senorx, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK131654 Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue…Senorx, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK153189 Beacon Tissue Marker (SE)Scion Medical Technologies, LLC · 2015
Most influential descendants
Showing 3 of 3 · See all- K081085Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GSSenorx, Inc. · 2008 · cites it directly2descendants
- K131654Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerSenorx, Inc. · 2013 · 2 generations on1descendant
- K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031938 | Gel Mark Iii Biopsy Site Marker | Senorx, Inc. | 2003 | — |
| +1 | K081085 | Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GS | Senorx, Inc. | 2008 | — |
| +2 | K131654 | Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker | Senorx, Inc. | 2013 | — |
| +3 | K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | — | Gel Mark Biopsy Site Marker Named without a submission number | |
| * | — | Gel Mark Ultra Biopsy Site Marker Named without a submission number | |
| * | — | MammoMark Biopsy Site Marker Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081085 | Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GS | 2008 | 2 |
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?
- Of its descendants, K081085 (Senorx, Inc., 2008) has gone furthest, with 2 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?
The Gel Mark III is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031938: Gel Mark Iii Biopsy Site Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031938
Report an extraction error
Are you the manufacturer?
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