Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
El.En S.P.A. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
204 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260647 | SPECCHIO | El.En S.P.A. | 2026-04-02 | 34 | 0 |
| K251432 | Olo | El.En S.P.A. | 2025-08-06 | 90 | 0 |
| K243683 | Deka Bluebeam | El.En S.P.A. | 2025-06-12 | 195 | 0 |
| K250281 | DEKA LOTUS | El.En S.P.A. | 2025-02-26 | 26 | 0 |
| K241459 | MOTUS PRO Family | El.En S.P.A. | 2024-06-21 | 29 | 0 |
| K233473 | DEKA LOTUS | El.En S.P.A. | 2024-05-16 | 204 | 0 |
| K240752 | DEKA TORO | El.En S.P.A. | 2024-05-16 | 58 | 0 |
| K234057 | NIRVANA | El.En S.P.A. | 2024-04-10 | 110 | 0 |
| K240537 | SMARTXIDE PRO | El.En S.P.A. | 2024-03-20 | 23 | 0 |
| K240497 | Smartxide Tetra Pro | El.En S.P.A. | 2024-03-12 | 21 | 0 |
| K233470 | DEKA LILY | El.En S.P.A. | 2023-12-19 | 55 | 0 |
| K233090 | DEKA AGAIN PRO family | El.En S.P.A. | 2023-10-27 | 31 | 0 |
| K231971 | DEKA PHYSIQ 360 | El.En S.P.A. | 2023-09-26 | 85 | 0 |
| K232334 | DEKA SIMON | El.En S.P.A. | 2023-09-01 | 28 | 0 |
| K133895 | DEKA SMARTXIDE LASER SYSTEM | El.En S.P.A. | 2014-09-05 | 259 | 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