510(k) · Cleared
ClearedColonosight Model 510B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sightline Technologies, Ltd. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Mar 5, 2004 as substantially equivalent to K961570 (Pentax Precision Instrument Corp., 1996) and 7 other predicates after a 189-day review. Its family tree reaches back 4 generations to 1992. 38 later devices descend from it.
- Decided
- Mar 5, 2004
- Review
- 189 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 4 generations to K921244 (1992). 20 ancestors in all, the oldest K822846 (1982). 38 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 3 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 2 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 1 generation backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- This deviceK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- Descendant · cites it directly · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010
- Descendant · cites it directly · 9 of its ownK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K091305ClearpathEasyglide, Ltd. · 2009 · cites it directly13descendants
- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · cites it directly13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · cites it directly12descendants
- K093779Clearpath UgiEasyglide, Ltd. · 2010 · 2 generations on10descendants
- K081004Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −3 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −2 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −1 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| 0 (this device) | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| +1 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| +1 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +1 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +2 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
| +1 | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961570 | Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Summary page 5…ual Name Colonoscope and Accessories Classification Name Colanoscope and Accessories K632 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight… | 1996 |
| * | K961563 | EC-384OTL, Video ColonscopeSummary page 5…Colonoscope and Accessories Classification Name Colanoscope and Accessories K632 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130,… | 1996 |
| * | K951579 | EC-3800TL, Video ColonoscopeSummary page 5…and Accessories Classification Name Colanoscope and Accessories K632 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782).… | 1996 |
| * | K990354 | EndosheathSummary page 5…fication Name Colanoscope and Accessories K632 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782). Intended Use The Colon… | 1999 |
| * | K012543 | Vision Sciences Endosheath SystemSummary page 5…Name Colanoscope and Accessories K632 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782). Intended Use The ColonoSight Mo… | 2002 |
| * | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath SystemSummary page 5…cope and Accessories K632 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782). Intended Use The ColonoSight Model 510B is i… | 2002 |
| * | K943895 | Vision System ColonscopeSummary page 5…32 GFY ,@7( Zfzéz Predicate Devices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782). Intended Use The ColonoSight Model 510B is intended to provide visualization (via a… | 1995 |
| * | K994130 | Rectosight RS 300-04Summary page 5…ices Pentax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782). Intended Use The ColonoSight Model 510B is intended to provide visualization (via a video monitor) and therapeutic… | 2000 |
| Kept off the family tree | K011782 | Sightline RectoSight Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…ax Video Colonoscopes (K961570, K961563, and K951579). EndoSheath® (K990354, K012543, and K021344), with VSI C-F100 Colonoscope (K943895), Sightline RectoSight (K994130, K01 1782). Intended Use The ColonoSight Model 510B is intended to provide visualization (via a video monitor) and therapeutic access to… |
What descends from it? (38)
See all 386 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 12 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K091305 (Easyglide, Ltd., 2009) has gone furthest, with 13 descendants of its own.
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 ColonoSight provides visualization and therapeutic access to the lower gastrointestinal tract. Visualization is provided via a video monitor. The lower gastrointestinal tract includes, but is not restricted to, the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
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/K032688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032688: Colonosight Model 510B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032688
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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