Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scanditronix Medical AB · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011763 | OMNIDOS | Scanditronix Medical AB | 2001-09-05 | 90 | 0 |
| K002051 | INVIDOS | Scanditronix Medical AB | 2000-09-05 | 61 | 0 |
| K990734 | DPD-12PCC | Scanditronix Medical AB | 1999-05-28 | 84 | 0 |
| K961400 | RFA-300, LDA UTILITY | Scanditronix Medical AB | 1997-01-03 | 267 | 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