# K032688: Colonosight Model 510B

- Pathway: 510(k) (Traditional)
- Applicant: Sightline Technologies, Ltd.
- Decided: Mar 5, 2004 after 189 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921244 (1992). 20 ancestors in all.
38 later devices descend from it; 6 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961570: Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length), Pentax Precision Instrument Corp. (1996) Summary page 5.
- K961563: EC-384OTL, Video Colonscope, Pentax Precision Instrument Corp. (1996) Summary page 5.
- K951579: EC-3800TL, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 5.
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 5.
- K012543: Vision Sciences Endosheath System, Vision-Sciences, Inc. (2002) Summary page 5.
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System, Vision-Sciences, Inc. (2002) Summary page 5.
- K943895: Vision System Colonscope, Vision-Sciences, Inc. (1995) Summary page 5.
- K994130: Rectosight RS 300-04, Sightline Technologies, Ltd. (2000) Summary page 5.

## Cited in the summary but 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.

## Most influential descendants
- K091305: Clearpath (2009), 13 descendants of its own
- K052930: Navigator Endoscopy System (2006), 13 descendants of its own
- K070622: Neoguide Endoscopy System (2007), 12 descendants of its own
- K093779: Clearpath Ugi (2010), 10 descendants of its own
- K081004: Protectiscope CS Colonoscope, Non-Intrapull (2008), 9 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032688
Methodology: https://510kreport.com/methodology