Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Astra Meditec AB · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920819 | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | 1993-03-24 | 394 | 0 |
| K896750 | LOFRIC(R), LOFRIC(R) CATH-KIT | Astra Meditec AB | 1990-08-06 | 249 | 0 |
| K882578 | ASTRA DENTAL IMPLANT SYSTEM | Astra Meditec AB | 1988-08-12 | 51 | 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