510(k) · Cleared
ClearedThird Eye Retroscope Auxiliary Endoscope 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 Jul 7, 2009 as substantially equivalent to K083180 (Avantis Medical Systems, Inc., 2009) after a 20-day review. Its family tree reaches back 5 generations to 1986. 4 later devices descend from it.
- Decided
- Jul 7, 2009
- Review
- 20 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K853585 (1986). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 4 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 3 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 2 generations backK070330 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007
- 1 generation backK083180 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- This deviceK091783 Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK093187 Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK140595 Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK180911 Visura Technologies TEECAD SystemVisura Technologies, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK160356 Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K093187Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009 · cites it directly3descendants
- K140595Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2014 · cites it directly2descendants
- K180911Visura Technologies TEECAD SystemVisura Technologies, LLC · 2018 · 2 generations on0descendants
- K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −4 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −3 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −2 | K070330 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2007 | — |
| −1 | K083180 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2009 | — |
| 0 (this device) | 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 | — |
| +1 | K140595 | Third Eye Panoramic Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2014 | — |
| +2 | K180911 | Visura Technologies TEECAD System | Visura Technologies, LLC | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K083180 | Third Eye Retroscope Auxiliary Endoscopy SystemSummary page 1…f Predicate Device: The Avantis Third Eye is substantially equivalent in operation and fundamental scientific technology to its previous version cleared under K0831 80. d) Device Description Summary: The Third Eye System consists of both disposable portions and facility equipment. The… | 2009 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K093187 (Avantis Medical Systems, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K083180.
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. 2009, 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 is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091783: Third Eye Retroscope Auxiliary Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091783
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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