510(k) · Cleared
ClearedNvision Vle Imaging System, Nvision Vle Catheter
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 Dec 16, 2011 as substantially equivalent to K033783 (Imalux Coporation, 2004) and 3 other predicates after an 84-day review. Its family tree reaches back 5 generations to 1989. 9 later devices descend from it.
- Decided
- Dec 16, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K895614 (1989). 15 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 4 generations backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- 3 generations backK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- 2 generations backK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- 1 generation backK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- This deviceK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 2 of its ownK153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon…Ninepoint Medical, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK182261 NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · cites it directly6descendants
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 2015 · 2 generations on5descendants
- K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc. · 2016 · 3 generations on2descendants
- K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc. · 2018 · 4 generations on1descendant
- K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −4 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −3 | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| −2 | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | 3 |
| −1 | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| 0 (this device) | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| +1 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| +2 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
| +3 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE… | Ninepoint Medical, Inc. | 2016 | — |
| +4 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2018 | — |
| +3 | K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K033783 | Imalux Oct Imaging SystemSummary page 1…pulsed echo imaging system Regulation Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class 11 3. Predicate Devices: Imalux OCT Imaging System - K033783 Imalux OCT Niris System - K042894 Imalux OCT Probe Sheath - K041 077 Tomophase OCTIS - K102599 Pr… | 2004 |
| * | K042894 | Imalux Niris Imaging SystemSummary page 1…tion Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class 11 3. Predicate Devices: Imalux OCT Imaging System - K033783 Imalux OCT Niris System - K042894 Imalux OCT Probe Sheath - K041 077 Tomophase OCTIS - K102599 Premarket Notification, Alvision VLE Im… | 2004 |
| * | K041077 | Imalux Oct Probe GuideSummary page 1…ct Code: NQQ Classification: Class 11 3. Predicate Devices: Imalux OCT Imaging System - K033783 Imalux OCT Niris System - K042894 Imalux OCT Probe Sheath - K041 077 Tomophase OCTIS - K102599 Premarket Notification, Alvision VLE Imaging System Proprieta… | 2004 |
| * | K102599 | Tomophase OctisSummary page 1…: Class 11 3. Predicate Devices: Imalux OCT Imaging System - K033783 Imalux OCT Niris System - K042894 Imalux OCT Probe Sheath - K041 077 Tomophase OCTIS - K102599 Premarket Notification, Alvision VLE Imaging System Proprietary and Confidential Informati… | 2010 |
What descends from it? (9)
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 22 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K120800 (Ninepoint Medical, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K033783.
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. 2011, 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 by providing two-dimensional, cross sectional, real-time depth visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112770: Nvision Vle Imaging System, Nvision Vle Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112770
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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