Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ilex 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) |
|---|---|---|---|---|---|
| K860639 | IONIZED CALCIUM AND BLOOD PH TESTCARDS | Ilex Corp. | 1986-04-21 | 60 | 0 |
| K860543 | BLOOD UREA NITROGEN (BUN) TESTCARD | Ilex Corp. | 1986-04-21 | 67 | 0 |
| K853068 | ILEX PROMPT CLINICAL CHEMISTRY ANALYER | Ilex Corp. | 1985-10-31 | 101 | 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