Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vitel Net · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040581 | MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM | Vitel Net | 2004-05-27 | 84 | 0 |
| K000557 | MEDVIZER PACS, MODEL RELEASE 2000 | Vitel Net | 2000-04-24 | 66 | 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