Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vivosonic, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
264 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024-12-19 | 85 | 0 |
| K080060 | VIVOSONIC NEUROSCREEN | Vivosonic, Inc. | 2008-04-04 | 86 | 0 |
| K043396 | INTEGRITY, MODEL V500 | Vivosonic, Inc. | 2005-01-24 | 45 | 0 |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | Vivosonic, Inc. | 2003-10-27 | 27 | 0 |
| K003364 | VIVO 200 DPS VIVOSCAN | Vivosonic, Inc. | 2001-07-18 | 264 | 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