Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitalog Corp. — 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) |
|---|---|---|---|---|---|
| K874198 | VITALOG HMS-3000 | Vitalog Corp. | 1988-03-22 | 165 | 0 |
| K871813 | VITALOG PMS-8 (MODIFICATION) | Vitalog Corp. | 1987-11-23 | 199 | 0 |
| K845051 | VITALOG PMS-8 | Vitalog Corp. | 1985-05-15 | 147 | 0 |
| K812739 | VITALOG PMS-8 MONITOR | Vitalog Corp. | 1981-12-29 | 91 | 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