Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Data Critical Corporation — 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) |
|---|---|---|---|---|---|
| K011436 | MOBILE-PATIENT VIEWER | Data Critical Corporation | 2001-07-05 | 56 | 0 |
| K962473 | (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBU | Data Critical Corporation | 1997-11-06 | 499 | 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