510(k) · Cleared
ClearedGeneral and Plastic Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scion Medical Technologies, LLC · NEU Marker, Radiographic, Implantable
Cleared on May 20, 2014 as substantially equivalent to K130763 (Scion Medical Technologies, LLC, 2013) and 2 other predicates after a 48-day review. Its family tree reaches back 7 generations to 2001. 3 later devices descend from it.
- Decided
- May 20, 2014
- Review
- 48 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001807 (2001). 13 ancestors in all, the oldest K970817 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 6 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 5 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 4 generations backK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- 3 generations backK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- 2 generations backK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
- 1 generation backK130763 Beacon Tissue MarkerScion Medical Technologies, LLC · 2013
- This deviceK140835 General and Plastic SurgeryScion Medical Technologies, LLC · 2014
- Descendant · cites it directly · 0 of its ownK170026 Radiopaque Tissue MarkerViscus Biologics, LLC · 2017
- Descendant · cites it directly · 0 of its ownK170905 Star Tissue MarkerScion Medical Technologies, LLC · 2017
- Descendant · cites it directly · 0 of its ownK153189 Beacon Tissue Marker (SE)Scion Medical Technologies, LLC · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −6 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −5 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −4 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| −3 | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| −2 | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
| −1 | K130763 | Beacon Tissue Marker | Scion Medical Technologies, LLC | 2013 | — |
| 0 (this device) | K140835 | General and Plastic Surgery | Scion Medical Technologies, LLC | 2014 | — |
| +1 | K170026 | Radiopaque Tissue Marker | Viscus Biologics, LLC | 2017 | — |
| +1 | K170905 | Star Tissue Marker | Scion Medical Technologies, LLC | 2017 | — |
| +1 | K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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.
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 |
|---|---|---|---|
| * | K130763 | Beacon Tissue MarkerSummary page 1…ication of Class 11,21 CFR 878.4300 Device: ___________________________ Product Code: NEU Predicate Beacon Tissue Marker K130763 May 8th, 2013 Device: Device The proposed Beacon Tissue Marker consists of a radiographic Description:… | 2013 |
| * | K093473 | KMD-MARK1 Tissue MarkerSummary page 2…sue Marker (K130763) cleared on May 8th, 2Q13 which is comprised of the Kent Medical Devices, Inc. KMD-Markl Tissue Marker (K093473), which was determined to be substantially equivalent and cleared on July 02, 2010,… | 2010 |
| * | K063193 | Modification to Biomarc Tissue MarkerSummary page 2…be substantially equivalent and cleared on July 02, 2010, and the Carbon Medical Technologies, Inc. BiomarC Tissue Marker (K063193), which was determined to be substantially equivalent and cleared on November 21, 2006.… | 2006 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K170026 (Viscus Biologics, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130763.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140835: General and Plastic Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140835
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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