510(k) · Cleared
ClearedNavigator Endoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoguide Systems, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jan 31, 2006 as substantially equivalent to K001241 (The Olympus Optical Co., 2000) and 3 other predicates after a 104-day review. Its family tree reaches back 5 generations to 1992. 13 later devices descend from it.
- Decided
- Jan 31, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921244 (1992). 28 ancestors in all, the oldest K822846 (1982). 13 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 4 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 3 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 2 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 1 generation backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- This deviceK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide 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 · 2 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK162330 Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation · 2017 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · cites it directly12descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · cites it directly6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on5descendants
- K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 2 generations on2descendants
- K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −4 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −3 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −2 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −1 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| 0 (this device) | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +1 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +1 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K141286 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2014 | — |
| +2 | K162330 | Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 1…redicate Devices: The NeoGuide Endoscopy System is substantially equivalent in intended use and method of operation to a combination of the following predicate devices: K001241 - Olympus Optical Co, Ltd. EVIS EXERA Colonovideoscope K961563 - Pentax Precision Instrument Corporation EC3840TL, Video Colonosc… | 2000 |
| * | K961563 | EC-384OTL, Video ColonscopeSummary page 1…ly equivalent in intended use and method of operation to a combination of the following predicate devices: K001241 - Olympus Optical Co, Ltd. EVIS EXERA Colonovideoscope K961563 - Pentax Precision Instrument Corporation EC3840TL, Video Colonoscope K032688 - Sightline, Colonosight, Video Colonoscope K033954… | 1996 |
| * | K032688 | Colonosight Model 510BSummary page 1…following predicate devices: K001241 - Olympus Optical Co, Ltd. EVIS EXERA Colonovideoscope K961563 - Pentax Precision Instrument Corporation EC3840TL, Video Colonoscope K032688 - Sightline, Colonosight, Video Colonoscope K033954 - USGI Shape Locking Endoscopic Overtube Device Description: Ihe NeoGuide… | 2004 |
| * | K033954 | Shape Locking Endoscopic OvertubeSummary page 1…al Co, Ltd. EVIS EXERA Colonovideoscope K961563 - Pentax Precision Instrument Corporation EC3840TL, Video Colonoscope K032688 - Sightline, Colonosight, Video Colonoscope K033954 - USGI Shape Locking Endoscopic Overtube Device Description: Ihe NeoGuide Endoscopy System has many features in common with cu… | 2004 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K070622 (Neoguide Systems, Inc., 2007) has gone furthest, with 12 descendants of its own.
- 14 other devices also cite its predicate K001241.
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.
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 NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052930: Navigator 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/K052930
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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