Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Varian, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
68 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060896 | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT | Varian, Inc. | 2006-06-09 | 67 | 0 |
| K051235 | ON TRAK TESTCARD | Varian, Inc. | 2005-06-08 | 26 | 0 |
| K050321 | ONTRAK TESTCARD 9 | Varian, Inc. | 2005-04-18 | 68 | 0 |
| K033902 | ONTRAK TESTCUP II AND ONSITE CUPKIT | Varian, Inc. | 2004-01-20 | 34 | 0 |
| K033659 | VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK | Varian, Inc. | 2004-01-06 | 46 | 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