Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Western Advanced Technology, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
336 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K822411 | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 | Western Advanced Technology, Inc. | 1983-07-12 | 336 | 0 |
| K813557 | AUDITORY STIMULATOR | Western Advanced Technology, Inc. | 1982-01-19 | 28 | 0 |
| K812138 | TENS DEVICE | Western Advanced Technology, Inc. | 1981-08-20 | 23 | 0 |
| K811790 | OCTOTOXIC SCREENER | Western Advanced Technology, Inc. | 1981-07-15 | 21 | 0 |
| K811772 | AUDITORY LOCALIZER | Western Advanced Technology, Inc. | 1981-07-15 | 23 | 0 |
| K802324 | E1 SERIES HEARING AID | Western Advanced Technology, Inc. | 1980-10-10 | 17 | 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