Cleared Traditional

Atmo Gas Capsule System

K250940 · Atmo Biosciences, Ltd. · Gastroenterology & Urology
Jun 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250940 is an FDA 510(k) clearance for the Atmo Gas Capsule System, a Gastrointestinal Motility System, Capsule (Class II — Special Controls, product code NYV), submitted by Atmo Biosciences, Ltd. (Box Hill, AU). The FDA issued a Cleared decision on June 26, 2025, 90 days after receiving the submission on March 28, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.

Submission Details

510(k) Number K250940 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date June 26, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code NYV — Gastrointestinal Motility System, Capsule
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1725
Definition Used To Evaluate Gi Motility Disorders And Indicated For Use In Evaluating Patients With Suspected Motility Disorders.