Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocare Corp. — 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) |
|---|---|---|---|---|---|
| K091414 | VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH | Biocare Corp. | 2009-10-21 | 161 | 0 |
| K012829 | STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRI | Biocare Corp. | 2001-11-02 | 71 | 0 |
| K002855 | BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER | Biocare Corp. | 2000-10-12 | 29 | 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