Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cochlear — 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) |
|---|---|---|---|---|---|
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); | Cochlear | 2025-05-29 | 125 | 0 |
| K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Coch | Cochlear | 2023-08-18 | 113 | 0 |
| K223672 | Instrument Case P1340904 | Cochlear | 2023-03-21 | 104 | 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