Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cane S.R.L. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
211 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091042 | CRONO S-PID 50 | Cane S.R.L. | 2009-05-12 | 29 | 0 |
| K052218 | CRONO FIVE AND CRONO PCA 50 | Cane S.R.L. | 2005-11-23 | 100 | 1 |
| K052219 | CRONO GO. | Cane S.R.L. | 2005-09-13 | 29 | 1 |
| K052217 | CRONO SUPER PID | Cane S.R.L. | 2005-09-13 | 29 | 1 |
| K042085 | CRONO F | Cane S.R.L. | 2004-09-17 | 45 | 1 |
| K041414 | CRONO AND CRONO, MODEL 30 | Cane S.R.L. | 2004-07-08 | 42 | 1 |
| K013840 | MICROJET CRONO PAR AND CRONO APO-GO | Cane S.R.L. | 2002-05-14 | 176 | 0 |
| K013822 | MICROJET CRONO PCA | Cane S.R.L. | 2002-05-08 | 173 | 0 |
| K013234 | MICROJET CRONO | Cane S.R.L. | 2002-04-26 | 211 | 0 |
| K013807 | MICROJET QUARK, MODEL U100 OR U40 | Cane S.R.L. | 2001-12-12 | 27 | 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