510(k) · Cleared
ClearedThird Eye Retroscope 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 Apr 24, 2007 as substantially equivalent to K032177 (Olympus Opto-Electronics Co., Ltd., 2003) and 3 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1986. 13 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K853585 (1986). 7 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- This deviceK070330 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · cites it directly · 5 of its ownK083180 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK091783 Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK093187 Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · cites it directly6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on5descendants
- K083180Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009 · cites it directly5descendants
- K091783Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009 · 2 generations on4descendants
- K093187Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| 0 (this device) | K070330 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2007 | — |
| +1 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +1 | 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 | — |
| +3 | K093187 | Modification to Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2009 | — |
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 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K032177 | Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I…Summary page 4…Identification of Predicate Devices: The Avantis Third Eye Retroscope is substantially equivalent in intended use and operation to a combination of predicate devices: K032177 Olympus Evis CF-140L/I/S Colonovideoscope (see note 1) K853585 Olympus Evis Video System Center CV-100 (see note 2) K924106 US… | 2003 |
| * | K853585 | Olympus Evs-Endoscopic Video Image & Data SysSummary page 4…roscope is substantially equivalent in intended use and operation to a combination of predicate devices: K032177 Olympus Evis CF-140L/I/S Colonovideoscope (see note 1) K853585 Olympus Evis Video System Center CV-100 (see note 2) K924106 US Endoscopy, Disposable Biopsy Forceps, Colonoscope, and fenestrat… | 1986 |
| * | K924106 | Biopsy ForcepsSummary page 4…ion to a combination of predicate devices: K032177 Olympus Evis CF-140L/I/S Colonovideoscope (see note 1) K853585 Olympus Evis Video System Center CV-100 (see note 2) K924106 US Endoscopy, Disposable Biopsy Forceps, Colonoscope, and fenestrated Oval cup with Spike and Sheath, part number 00711205 K9843… | 1992 |
| * | K984358 | Olympus Distal Attachment, Models…Summary page 4…eo System Center CV-100 (see note 2) K924106 US Endoscopy, Disposable Biopsy Forceps, Colonoscope, and fenestrated Oval cup with Spike and Sheath, part number 00711205 K984358 Olympus Distal Attachment Note 1 ~ No direct 510K was found for the CF-140L/I/S under FDF classification code. This product is c… | 1999 |
What descends from it? (13)
See all 133 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 21 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K100624 (Invendo Medical Gbmh, 2012) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K032177.
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. 2007, 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 Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070330: Third Eye Retroscope Auxiliary Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070330
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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