Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Audioscience, 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) |
|---|---|---|---|---|---|
| K936007 | PRIZM HEARING SYSTEM, MODEL POWER BTE | Audioscience, Inc. | 1994-03-04 | 78 | 0 |
| K930909 | PRIZM HEARING SYSTEM | Audioscience, Inc. | 1993-08-09 | 180 | 0 |
| K922422 | PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES | Audioscience, Inc. | 1992-06-10 | 20 | 0 |
| K902846 | PRIZM HEARING SYSTEM | Audioscience, Inc. | 1990-10-31 | 125 | 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