Alimetry , Ltd.: FDA clearances and approvals
Alimetry , Ltd. has 6 FDA 510(k) clearances (first 2022, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 104 days. Since 2017 its median was 104 days, against 116 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 170 |
| 2023 | 2 | 114 |
| 2024 | 1 | 89 |
| 2025 | 1 | 119 |
| 2026 | 1 | 59 |
Review time against the same product codes
Since 2017, Alimetry , Ltd.'s cleared 510(k)s took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MYE | System, Electrogastrography (Egg) | 6 | 6 |
Review panels
Most recent Alimetry , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262292 | Gastric Alimetry | MYE | 2026-09-04 | 59 |
| K252504 | Gastric Alimetry | MYE | 2025-12-05 | 119 |
| K240946 | Gastric Alimetry | MYE | 2024-07-03 | 89 |
| K232925 | Gastric Alimetry System | MYE | 2023-11-17 | 59 |
| K223398 | Gastric Alimetry System | MYE | 2023-04-27 | 170 |
| K213924 | Gastric Alimetry System | MYE | 2022-06-03 | 170 |
Recalls
openFDA lists no recalls under a recalling firm named Alimetry , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Alimetry , Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06500130: Effects of Liraglutide on Body Surface Gastric Mapping (Completed, started 2024-05-30)
Frequently asked questions
How many FDA 510(k) clearances does Alimetry , Ltd. have?
Alimetry , Ltd. has 6 FDA 510(k) clearances (first 2022, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Alimetry , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Alimetry , Ltd.'s cleared 510(k)s is 104 days. Since 2017: 104 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Alimetry , Ltd. make?
Its most frequent FDA product codes are MYE (System, Electrogastrography (Egg), 6).
Has Alimetry , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alimetry , Ltd. Related entities may recall under other names.
Next steps
- See all 6 Alimetry , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MYE, Alimetry , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.