Triton 1 System— 510(k) K260503
Substantially EquivalentNeptune Medical, Inc.
FDA 510(k) clearance K260503 for Triton 1 System, Substantially Equivalent on 2026-09-03. Applicant: Neptune Medical, Inc.. Device class: 2.
Summary
Neptune Medical's Triton 1 System is filed under FDF, flexible or rigid colonoscopes and accessories. The name is generic, and the record doesn't say what parts make up the system.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Neptune Medical filed from Burlingame, California. The decision came 198 calendar days after receipt (February 17 to September 3, 2026).
Clearance details
- Applicant
- Neptune Medical, Inc.
- Product code
- Product code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlingame, CA, US
Recent devices under product code FDF
view allMore clearances from Neptune Medical, Inc.
view allAdverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.