510(k) · Decided
Recalled · Class II · 2018NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ninepoint Medical, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Feb 6, 2015 as substantially equivalent to K120800 (Ninepoint Medical, Inc., 2013) after a 44-day review. Its family tree reaches back 7 generations to 1989. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 6, 2015
- Review
- 44 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K895614 (1989). 17 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 6 generations backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- 5 generations backK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- 4 generations backK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- 3 generations backK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- 2 generations backK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- 1 generation backK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- This deviceK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015
- 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 · cites it directly · 1 of its ownK182261 NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK251730 LIA Console (542-7)Leadoptik, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK191117 NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc. · 2019
Most influential descendants
Showing 5 of 5 · 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
- K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018 · cites it directly1descendant
- K251730LIA Console (542-7)Leadoptik, Inc. · 2025 · 3 generations on0descendants
- K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −6 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −5 | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| −4 | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | 3 |
| −3 | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| −2 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| −1 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| 0 (this device) | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | — |
| +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 | — |
| +1 | K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018 | — |
| +3 | K251730 | LIA Console (542-7) | Leadoptik, Inc. | 2025 | — |
| +2 | K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K120800 | Nvision Vle Imaging SystemSummary page 5…: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class |l Predicate Devices: NvisionVLE™ Imaging System, K120800 Device Description: The NinePoint Medical NvisionVLE™ Imaging System is a general imaging system comprised of the NvisionVLE™… | 2013 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2018 | Class II | Z-1781-2018 | Process control | Distal tips of the probes may detach from the probe shaft during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K153479 (Ninepoint Medical, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.
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/K143678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143678
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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