Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sophono, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
292 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Co | Sophono, Inc. | 2016-06-16 | 205 | 0 |
| K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM | Sophono, Inc. | 2013-11-22 | 130 | 0 |
| K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2013-04-08 | 103 | 0 |
| K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND | Sophono, Inc. | 2011-05-23 | 292 | 0 |
| K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2010-05-18 | 116 | 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