510(k) · Cleared
ClearedKMD-MARK1 Tissue Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kent Medical Devices, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Jul 2, 2010 as substantially equivalent to K072219 (Cytophil, Inc., 2008) and 1 other predicate after a 238-day review. Its family tree reaches back 5 generations to 2001. 9 later devices descend from it.
- Decided
- Jul 2, 2010
- Review
- 238 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001807 (2001). 11 ancestors in all, the oldest K970817 (1997). 9 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 4 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 3 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 2 generations backK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
- 1 generation backK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
- This deviceK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK130763 Beacon Tissue MarkerScion Medical Technologies, LLC · 2013
- Descendant · cites it directly · 3 of its ownK140835 General and Plastic SurgeryScion Medical Technologies, LLC · 2014
- Descendant · cites it directly · 1 of its ownK133697 Breast-Med Tissue MarkerBreast-Med, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK251989 VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230836 SchurSign Tissue MarkerSurgmark GmbH · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130763Beacon Tissue MarkerScion Medical Technologies, LLC · 2013 · cites it directly5descendants
- K140835General and Plastic SurgeryScion Medical Technologies, LLC · 2014 · cites it directly3descendants
- K133697Breast-Med Tissue MarkerBreast-Med, Inc. · 2015 · cites it directly1descendant
- K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025 · 2 generations on0descendants
- K230836SchurSign Tissue MarkerSurgmark GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −4 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −3 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −2 | K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2006 | — |
| −1 | K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | 2007 | — |
| 0 (this device) | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
| +1 | K130763 | Beacon Tissue Marker | Scion Medical Technologies, LLC | 2013 | — |
| +1 | K140835 | General and Plastic Surgery | Scion Medical Technologies, LLC | 2014 | — |
| +1 | K133697 | Breast-Med Tissue Marker | Breast-Med, Inc. | 2015 | — |
| +2 | K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | 2025 | — |
| +2 | K230836 | SchurSign Tissue Marker | Surgmark GmbH | 2024 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K072219 | Cytophil Tissue MarkerSummary page 1…MD-Markl Tissue Marker was shown to be substantially equivalent to the following previously cleared devices and has the same indications for use, design, and function: K072219 Cytophil Tissue Marker K070436 BiomarC Tissue Marker Kent Medical Devices, Inc.… | 2008 |
| * | K070436 | Biomarc Gold Tissue MarkerSummary page 1…to be substantially equivalent to the following previously cleared devices and has the same indications for use, design, and function: K072219 Cytophil Tissue Marker K070436 BiomarC Tissue Marker Kent Medical Devices, Inc. Con… | 2007 |
What descends from it? (9)
4 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 9 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K130763 (Scion Medical Technologies, LLC, 2013) has gone furthest, with 5 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. 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 KMD-Markl Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093473: KMD-MARK1 Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093473
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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