Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vitalog Monitoring,Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935510 | VX4 RECORDING PULSE OXIMETER | Vitalog Monitoring,Inc. | 1994-07-01 | 227 | 0 |
| K914620 | HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION | Vitalog Monitoring,Inc. | 1992-05-01 | 198 | 0 |
| K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991-11-19 | 74 | 0 |
| K910950 | HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED | Vitalog Monitoring,Inc. | 1991-08-02 | 157 | 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