Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paramed S.R.L. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
175 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151466 | MrOpen | Paramed S.R.L. | 2015-10-15 | 136 | 0 |
| K122034 | MRJ 3300 | Paramed S.R.L. | 2012-12-06 | 148 | 0 |
| K121249 | MULTIARRAY KIT | Paramed S.R.L. | 2012-06-12 | 48 | 0 |
| K101295 | MROPEN | Paramed S.R.L. | 2010-07-28 | 79 | 0 |
| K100164 | MR INSPIRE WITH EXTENDED KIT | Paramed S.R.L. | 2010-04-05 | 75 | 0 |
| K073362 | MROPEN | Paramed S.R.L. | 2008-05-23 | 175 | 0 |
| K080098 | MRJ EXTENDED | Paramed S.R.L. | 2008-03-10 | 56 | 0 |
| K033507 | MRJ | Paramed S.R.L. | 2004-01-20 | 76 | 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