510(k) · Decided
DecidedNvisionVLE Low-profile Optical Probe
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 Jul 19, 2019 as substantially equivalent to K182261 (Ninepoint Medical, Inc., 2018) after an 84-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Jul 19, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K895614 (1989). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 5 generations between
- 3 generations backK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- 2 generations backK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- 1 generation backK182261 NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018
- This deviceK191117 NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 8 generations backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- 7 generations backK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- 6 generations backK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- 5 generations backK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- 4 generations backK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- 3 generations backK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- 2 generations backK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- 1 generation backK182261 NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018
- This deviceK191117 NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −8 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −7 | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| −6 | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | 3 |
| −5 | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| −4 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| −3 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| −2 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
| −1 | K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K182261 | NvisionVLE Imaging System, NvisionVLE Optical ProbeSummary page 5…pulsed echo imaging system Regulation Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class II 3. Predicate Devices: NvisionVLE® Imaging System, K182261 4. Device Description: The NinePoint Medical NvisionVLE® Imaging System subject to this 510(k) is a general imaging syste… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 19 ancestors have a recall of any class.
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. 2019, 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 Low-Profile Optical Probe, as part of the NvisionVLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization.
The NvisionVLE Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191117: NvisionVLE Low-profile Optical Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191117
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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