510(k) · Cleared
ClearedThird Eye Panoramic Auxiliary Endoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avantis Medical Systems, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Nov 17, 2014 as substantially equivalent to K070330 (Avantis Medical Systems, Inc., 2007) and 3 other predicates after a 255-day review. Its family tree reaches back 7 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 17, 2014
- Review
- 255 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K853585 (1986). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 6 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 5 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 4 generations backK070330 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007
- 3 generations backK083180 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- 2 generations backK091783 Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009
- 1 generation backK093187 Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- This deviceK140595 Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK180911 Visura Technologies TEECAD SystemVisura Technologies, LLC · 2018
- Descendant · cites it directly · 0 of its ownK160356 Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −6 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −5 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −4 | K070330 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2007 | — |
| −3 | K083180 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2009 | — |
| −2 | K091783 | Third Eye Retroscope Auxiliary Endoscope System | Avantis Medical Systems, Inc. | 2009 | — |
| −1 | K093187 | Modification to Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2009 | — |
| 0 (this device) | K140595 | Third Eye Panoramic Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2014 | — |
| +1 | K180911 | Visura Technologies TEECAD System | Visura Technologies, LLC | 2018 | — |
| +1 | K160356 | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | Avantis Medical Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 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 |
|---|---|---|---|
| * | K070330 | Third Eye Retroscope Auxiliary Endoscopy SystemSummary page 4…vice (Panoramic Device) is substantially equivalent in operation and fundamental scientific technology to its previous version, the Retroscope, cleared under K070330, K083180, K091783 and K093187. Page 4-1 Confidential: This document an… | 2007 |
| * | K083180 | Third Eye Retroscope Auxiliary Endoscopy SystemSummary page 4…oramic Device) is substantially equivalent in operation and fundamental scientific technology to its previous version, the Retroscope, cleared under K070330, K083180, K091783 and K093187. Page 4-1 Confidential: This document and the inf… | 2009 |
| * | K091783 | Third Eye Retroscope Auxiliary Endoscope SystemSummary page 4…vice) is substantially equivalent in operation and fundamental scientific technology to its previous version, the Retroscope, cleared under K070330, K083180, K091783 and K093187. Page 4-1 Confidential: This document and the information… | 2009 |
| * | K093187 | Modification to Third Eye Retroscope Auxiliary Endoscopy SystemSummary page 4…ally equivalent in operation and fundamental scientific technology to its previous version, the Retroscope, cleared under K070330, K083180, K091783 and K093187. Page 4-1 Confidential: This document and the information contained herein m… | 2009 |
What descends from it? (2)
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K180911 (Visura Technologies, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070330.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140595: Third Eye Panoramic Auxiliary Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140595
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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