Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ralco S.R.L. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
168 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110856 | RALCO | Ralco S.R.L. | 2011-08-10 | 135 | 0 |
| K091517 | RALCO, MODEL R225 ACS | Ralco S.R.L. | 2009-07-14 | 53 | 0 |
| K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | 2008-12-05 | 56 | 0 |
| K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | 2007-11-26 | 59 | 0 |
| K030487 | R 72 | Ralco S.R.L. | 2003-08-01 | 168 | 0 |
| K946320 | R 302 | Ralco S.R.L. | 1995-05-11 | 134 | 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