# K260503: Triton 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Neptune Medical, Inc.
- Decided: Sep 3, 2026 after 198 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: 8 generations back to K931154 (1993). 57 ancestors in all.
No later device cites it as a predicate yet.
3 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070622: Neoguide Endoscopy System, Neoguide Systems, Inc. (2007) Summary page 5.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 5.

## Indications for use
The Triton 1 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.

Source page: https://510kreport.com/device/K260503
Methodology: https://510kreport.com/methodology