Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DreaMed Diabetes, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
299 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232722 | endo.digital Platform | DreaMed Diabetes, Ltd. | 2023-10-03 | 28 | 0 |
| K210561 | Advisor Pro Platform | DreaMed Diabetes, Ltd. | 2021-09-28 | 215 | 0 |
| K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020-08-28 | 86 | 0 |
| K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019-07-18 | 57 | 0 |
| DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018-06-12 | 299 | 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