510(k) · Cleared
ClearedThird Eye Panoramic Auxiliary Endoscopy System - Resposable
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 May 17, 2016 as substantially equivalent to K140595 (Avantis Medical Systems, Inc., 2014) after a 99-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- May 17, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K853585 (1986). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 7 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 6 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 5 generations backK070330 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007
- 4 generations backK083180 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- 3 generations backK091783 Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009
- 2 generations backK093187 Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- 1 generation backK140595 Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2014
- This deviceK160356 Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −7 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −6 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −5 | K070330 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2007 | — |
| −4 | K083180 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2009 | — |
| −3 | K091783 | Third Eye Retroscope Auxiliary Endoscope System | Avantis Medical Systems, Inc. | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K140595 | Third Eye Panoramic Auxiliary Endoscopy SystemSummary page 4…e (TEPR) is substantially equivalent in operation and fundamental scientific technology to its previous version, the single-use Panoramic Device, cleared under K140595. Page 4-1 K160356 Confidential:… | 2014 |
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 3.5 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K140595.
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. 2016, 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 – Resposable 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/K160356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160356: Third Eye Panoramic Auxiliary Endoscopy System - Resposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160356
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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