Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Audio Technologies S.R.L. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083780 | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABL | Audio Technologies S.R.L. | 2009-03-23 | 94 | 0 |
| K001142 | AUDIO TECHNOLOGIES S:R.1 | Audio Technologies S.R.L. | 2000-06-23 | 74 | 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