Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MYE · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
329 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252504 | Gastric Alimetry | Alimetry , Ltd. | 2025-12-05 | 119 | 0 |
| K240946 | Gastric Alimetry | Alimetry , Ltd. | 2024-07-03 | 89 | 0 |
| K232925 | Gastric Alimetry System | Alimetry , Ltd. | 2023-11-17 | 59 | 0 |
| K223398 | Gastric Alimetry System | Alimetry , Ltd. | 2023-04-27 | 170 | 0 |
| K213924 | Gastric Alimetry System | Alimetry , Ltd. | 2022-06-03 | 170 | 0 |
| K212954 | G-Tech Wireless Patch System (WPS) | G-Tech Medical | 2022-01-10 | 116 | 0 |
| K014269 | POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL | Medtronic Functional Diagnostics A/S | 2002-11-21 | 329 | 0 |
| DEN990005 | THE 3PM EGG MACHINE | 3pm Co., Inc. | 1999-08-20 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda