Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vicon Instrument Co. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
106 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811751 | FINETONE MODEL VI HEARING AID | Vicon Instrument Co. | 1981-07-15 | 23 | 0 |
| K790878 | SCREENING AUDIOMETER, HIGH FREQUENCY | Vicon Instrument Co. | 1979-08-03 | 88 | 0 |
| K790064 | TINNITUS DEVICES | Vicon Instrument Co. | 1979-02-16 | 32 | 0 |
| K771769 | TINNITUS MASKERS, MODELS S564&S574 | Vicon Instrument Co. | 1978-01-03 | 106 | 0 |
| K771762 | MODULAR HEARING DEVICE, MODEL S291 | Vicon Instrument Co. | 1977-10-04 | 15 | 0 |
| K770938 | TINNITUS AID, MODEL S244 | Vicon Instrument Co. | 1977-06-28 | 36 | 0 |
| K761216 | HEARING AIDS (MODEL E-552 S-712) | Vicon Instrument Co. | 1976-12-16 | 9 | 0 |
| K760215 | HEARING AID, S-522 FM | Vicon Instrument Co. | 1976-07-21 | 9 | 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