Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Audifon-USA, Inc. · 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) |
|---|---|---|---|---|---|
| K130514 | AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, | Audifon-USA, Inc. | 2013-11-21 | 267 | 0 |
| K130417 | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUD | Audifon-USA, Inc. | 2013-09-12 | 205 | 0 |
| K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | Audifon-USA, Inc. | 2012-11-01 | 135 | 0 |
| K083488 | JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT | Audifon-USA, Inc. | 2009-02-19 | 86 | 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