Gastroenterology-Urology · 510(k) · 2025
Gastric Alimetry
Alimetry , Ltd.. Cleared by FDA on 5 December 2025 under submission K252504, product code MYE (system, electrogastrography (egg)). What FDA's record says, in FDA's words.
Device record · K252504
- Device. Gastric AlimetryDEVICE
- Company. Alimetry , Ltd. (NZ)COMPANY
- Decision. 5 December 2025, 510(k), substantially equivalent (traditional review); received 8 August 2025DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. MYE, System, Electrogastrography (Egg)CODE
- Regulation. 21 CFR 876.1735, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K252504Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Gastric Alimetry Please provide your Indications for Use below. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The modified Gastric Alimetry System is indicated for patients 12 years and older. I Please select the types of uses (select one or both, as ZPrescription Use (Part 21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 801 Subpart C)applicable). Gastric Alimetry \\4148-9966-9071 v1 510(K) SUMMARY Alimetry’s Gastric Alimetry S ubmitter Alimetry Ltd. Address: 70 Symonds St. Grafton Auckland 1010 New Zealand Phone: +64 27 622 2306 Contact Person: Yaara Yarmut, Chief Regulatory Officer. Date Prepared: 8 August 2025 N ame of Device: Gastric Alimetry Common or Usual Name: Gastric Alimetry System
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code MYE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MYE, in Gastroenterology-Urology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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