Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cascination AG — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
250 daysmedian FDA review time
266 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242120 | OTOPLAN | Cascination AG | 2025-04-11 | 266 | 0 |
| K232022 | CAS-One IR | Cascination AG | 2024-03-13 | 250 | 0 |
| K220300 | OTOPLAN | Cascination AG | 2022-06-24 | 142 | 0 |
| K203486 | Otoplan | Cascination AG | 2021-08-20 | 266 | 0 |
| K152473 | CAS-One IR | Cascination AG | 2016-01-20 | 142 | 0 |
| K143024 | CAS-One Liver | Cascination AG | 2015-04-28 | 189 | 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