Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dideco S.R.L. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
212 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052717 | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER | Dideco S.R.L. | 2005-10-20 | 21 | 0 |
| K051232 | D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MIC | Dideco S.R.L. | 2005-05-20 | 7 | 0 |
| K050890 | ECC.O SYSTEM | Dideco S.R.L. | 2005-05-05 | 27 | 0 |
| K050447 | PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Dideco S.R.L. | 2005-03-08 | 14 | 1 |
| K043323 | D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL | Dideco S.R.L. | 2005-02-01 | 61 | 1 |
| K953835 | LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR | Dideco S.R.L. | 1996-03-15 | 212 | 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