Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Virion (U.S.), Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
201 daysmedian FDA review time
346 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933251 | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | Virion (U.S.), Inc. | 1994-06-13 | 346 | 0 |
| K921618 | COXSACKIE VIRUS B1-B6 CF ANTIGENS | Virion (U.S.), Inc. | 1992-06-29 | 84 | 0 |
| K905306 | MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN | Virion (U.S.), Inc. | 1991-06-17 | 201 | 0 |
| K905385 | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | Virion (U.S.), Inc. | 1991-03-21 | 111 | 0 |
| K864981 | TOXOPLASMA GONDII | Virion (U.S.), Inc. | 1987-10-30 | 312 | 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