Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scandidos AB — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
454 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223234 | Delta4 Insight | Scandidos AB | 2024-01-16 | 454 | 0 |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | Scandidos AB | 2019-04-08 | 103 | 0 |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos | Scandidos AB | 2016-01-29 | 246 | 0 |
| K151180 | ScandiDos Delta4 Phantom+ | Scandidos AB | 2015-08-19 | 107 | 0 |
| K052920 | DELTA4 | Scandidos AB | 2006-01-12 | 87 | 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