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StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

The Tracker / September 2026 / K260503

510(k) cleared

Triton 1 System

Neptune Medical, Inc. · Sep 3, 2026 · K260503 · In the directory

FDA cleared the Triton 1 System from Neptune Medical, Inc. on Sep 3, 2026 under K260503, a traditional 510(k). The device falls under product code FDF, Colonoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 17, 2026. The decision came 198 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neptune Medical, Inc. has one other decision in the tracker over the last 12 months: K262262 (Pathfinder Endoscope Overtube).

Questions & Answers

What did FDA clear under K260503?

K260503 is the FDA 510(k) for Triton 1 System, submitted by Neptune Medical, Inc.. FDA's decision date was Sep 3, 2026, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the Triton 1 System?

Neptune Medical, Inc., based in Burlingame, CA, is the applicant of record for K260503. The company is listed in the MedDevice Startups directory.

How long did the K260503 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Sep 3, 2026, 198 days later.

← All decisions in September 2026

Sources

In the startup directory

Neptune Medical

GI & Urology · Burlingame, CA