Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trutone — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
183 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973377 | SIBELMED AC50D | Trutone | 1998-03-10 | 183 | 0 |
| K972550 | AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC | Trutone | 1997-07-31 | 31 | 0 |
| K972552 | AUDIFON H20 PC/AUDIFON H32 PP | Trutone | 1997-07-30 | 30 | 0 |
| K972542 | JAZZ PP AGC-O, JAZZ PP | Trutone | 1997-07-23 | 14 | 0 |
| K972543 | TWIST PPAGC-1, TWIST PP | Trutone | 1997-07-23 | 14 | 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