Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
United Hearing Systems, Inc. — 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) |
|---|---|---|---|---|---|
| K050653 | TRANSEAR BONE CONDUCTION HEARING AID | United Hearing Systems, Inc. | 2005-07-01 | 112 | 0 |
| K970828 | UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,90 | United Hearing Systems, Inc. | 1997-05-28 | 83 | 0 |
| K892803 | PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 | United Hearing Systems, Inc. | 1989-06-22 | 66 | 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