Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vxr, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
79 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853703 | VENTREZYME T3 IMMUNOASSAY T3 | Vxr, Inc. | 1985-10-04 | 30 | 0 |
| K853748 | VENTRESCREEN HCG URINE | Vxr, Inc. | 1985-10-01 | 22 | 0 |
| K841456 | VENTREXYME EIA CONTROLS IMMUNOASSAY | Vxr, Inc. | 1984-05-21 | 42 | 0 |
| K840473 | VENTREZYME T4 IMMUNOASSAY T4 | Vxr, Inc. | 1984-04-04 | 61 | 0 |
| K833960 | VENTREX PREGNANCY TEST KIT ENZYME | Vxr, Inc. | 1984-02-03 | 79 | 0 |
| K833989 | VENTREZYME THEOPHYLLINE IMMUNOASSAY | Vxr, Inc. | 1984-01-30 | 73 | 0 |
| K833878 | VENTREZYME DIGOXIN IMMUNOASSAY DIGOX | Vxr, Inc. | 1984-01-13 | 66 | 0 |
| K833909 | VENTRESCREEN BETA-HCG ENZYME IMMUNO | Vxr, Inc. | 1983-11-21 | 7 | 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