Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vios Medical, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173107 | Vios Central Station Monitor Software, Vios Central Server S | Vios Medical, Inc. | 2018-07-26 | 300 | 0 |
| K172586 | Vios Monitoring Systemâ„¢ Model 2050 | Vios Medical, Inc. | 2018-06-22 | 298 | 4 |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015-12-16 | 245 | 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