510(k) · Cleared
ClearedSpot Endoscopic Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chek-Med Systems · NBG Marker, Colon
Cleared on Feb 18, 2000 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Feb 18, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- NBG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK993951 Spot Endoscopic MarkerChek-Med Systems · 2000
- Descendant · cites it directly · 2 of its ownK153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon…Ninepoint Medical, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK251730 LIA Console (542-7)Leadoptik, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK042901 Endomark Sterile India InkPmt Corp. · 2005
Most influential descendants
Showing 4 of 4 · See all- K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc. · 2016 · cites it directly2descendants
- K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc. · 2018 · 2 generations on1descendant
- K251730LIA Console (542-7)Leadoptik, Inc. · 2025 · 3 generations on0descendants
- K042901Endomark Sterile India InkPmt Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993951 | Spot Endoscopic Marker | Chek-Med Systems | 2000 | — |
| +1 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE… | Ninepoint Medical, Inc. | 2016 | — |
| +2 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2018 | — |
| +3 | K251730 | LIA Console (542-7) | Leadoptik, Inc. | 2025 | — |
| +1 | K042901 | Endomark Sterile India Ink | Pmt Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 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?
- Of its descendants, K153479 (Ninepoint Medical, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NBG devicesNBG Marker, Colon: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBG
FDA has decided no NBG device since 2007.
Median 510(k) review, days · NBG
Too few NBG 510(k)s in any year since 2007 to give a median.
Recalls per year · NBG
No recall names NBG since 2007.
Adverse event reports per year · NBG
5in 2022
MAUDE reports naming product code NBG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Spot™ is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will be removed surgically within (30) thirty days.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993951: Spot Endoscopic Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993951
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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