Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Institute Virion , Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
374 daysmedian FDA review time
374 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Institute Virion , Ltd. | 1986-09-30 | 68 | 0 |
| K843659 | INFLUENZA A2 VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843665 | PARAINFLUENZA 1 | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843657 | CYTOMEGALOVIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843676 | VARICELLA/ZOSTER VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843667 | PARAINFLUENZA 3 | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843660 | IN FLUENZA B VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843649 | ADENOVIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843658 | H. SIMPLEX VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843662 | MEASLES VIRUS RUBEOLA | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843654 | CHLAMYDIA | Institute Virion , Ltd. | 1985-08-08 | 325 | 0 |
| K843672 | Q-FEVER | Institute Virion , Ltd. | 1985-08-08 | 325 | 0 |
| K843668 | PHOTOMETER 90IYS | Institute Virion , Ltd. | 1984-10-30 | 43 | 0 |
| K843664 | MYCOPLASMA PNEUMONIAE | Institute Virion , Ltd. | 1984-10-25 | 38 | 0 |
| K843653 | CAMPYLOCACTER SUPPLEMENT | Institute Virion , Ltd. | 1984-10-23 | 36 | 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