Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Improved Hearing Service, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
71 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903862 | ITE HEARING AID, SOUND MED RUBY MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903861 | ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903863 | ITE HEARING AID, SOUND MED OPAL MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903859 | ITE HEARING AID, DIAMOND MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903865 | ITE HEARING AID, SOUND MED AMETHYST MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903864 | ITE HEARING AID, PEARL MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903415 | ITE HEARING AID, SOUND MED EMERALD MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K903860 | ITE HEARING AID, SAAPHIRE MODEL | Improved Hearing Service, Inc. | 1990-10-09 | 71 | 0 |
| K902290 | ITE HEARING AID MODEL PALOMINO | Improved Hearing Service, Inc. | 1990-08-01 | 71 | 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