FDA applicant
Alimetry, Ltd.
FDA records 6 decisions for Alimetry, Ltd. (Grafton, NZ) from 2022 to 2026: 6 510(k) clearances. All are in product code MYE (System, Electrogastrography (Egg)). Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alimetry, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2022high 2 (2023) · low 1 (2022)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Alimetry, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report