Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ETS · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
23 daysmedian FDA review time
32 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813557 | AUDITORY STIMULATOR | Western Advanced Technology, Inc. | 1982-01-19 | 28 | 0 |
| K811772 | AUDITORY LOCALIZER | Western Advanced Technology, Inc. | 1981-07-15 | 23 | 0 |
| K811790 | OCTOTOXIC SCREENER | Western Advanced Technology, Inc. | 1981-07-15 | 21 | 0 |
| K790064 | TINNITUS DEVICES | Vicon Instrument Co. | 1979-02-16 | 32 | 0 |
| K771188 | REVERSING CLICK GENERATOR RCG6 | Teca, Inc. | 1977-07-14 | 13 | 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