Cleared Traditional

K240946 - Gastric Alimetry (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240946 · Alimetry , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
89d
Days
Class 2
Risk

K240946 is an FDA 510(k) clearance for the Gastric Alimetry. Classified as System, Electrogastrography (egg) (product code MYE), Class II - Special Controls.

Submitted by Alimetry , Ltd. (Grafton, NZ). The FDA issued a Cleared decision on July 3, 2024 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1735 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alimetry , Ltd. devices

Submission Details

510(k) Number K240946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2024
Decision Date July 03, 2024
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYE System, Electrogastrography (egg)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1735
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MYE System, Electrogastrography (egg)

All 7
Devices cleared under the same product code (MYE) and FDA review panel - the closest regulatory comparables to K240946.
Gastric Alimetry
K252504 · Alimetry , Ltd. · Dec 2025
Gastric Alimetry System
K232925 · Alimetry , Ltd. · Nov 2023
Gastric Alimetry System
K223398 · Alimetry , Ltd. · Apr 2023
Gastric Alimetry System
K213924 · Alimetry , Ltd. · Jun 2022
G-Tech Wireless Patch System (WPS)
K212954 · G-Tech Medical · Jan 2022