Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mirada Medical, Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
246 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220779 | XD | Mirada Medical, Ltd. | 2022-04-15 | 29 | 0 |
| K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020-09-11 | 29 | 0 |
| K182016 | Simplicit90Y | Mirada Medical, Ltd. | 2018-12-06 | 132 | 0 |
| K181572 | Workflow Box | Mirada Medical, Ltd. | 2018-07-10 | 26 | 0 |
| K143020 | LiverMultiScan | Mirada Medical, Ltd. | 2015-06-23 | 246 | 0 |
| K130393 | MIRADA RTX | Mirada Medical, Ltd. | 2013-03-20 | 33 | 0 |
| K102687 | MIRADA RT | Mirada Medical, Ltd. | 2010-10-04 | 17 | 0 |
| K101228 | MIRADA XD | Mirada Medical, Ltd. | 2010-06-23 | 51 | 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