Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JWZ — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
212 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | Genzyme Corp. | 2004-04-02 | 112 | 0 |
| K020595 | XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 | Xenotope Diagnostics, Inc. | 2003-02-20 | 363 | 0 |
| K020226 | XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBER | Hellen Professional Services | 2002-08-22 | 212 | 0 |
| K894246 | MERIVIEW TM TRICHOMONAS | Meridian Diagnostics, Inc. | 1989-08-15 | 55 | 0 |
| K892802 | SUPER DUO | Mercia Diagnostics , Ltd. | 1989-06-13 | 57 | 0 |
| K892263 | MERIFLUOR(TM) -TRICHOMONAS | Meridian Diagnostics, Inc. | 1989-05-24 | 50 | 0 |
| K875138 | TRICHOMATE(R) SUPER | Mercia Diagnostics , Ltd. | 1988-05-13 | 150 | 0 |
| K874259 | TRICHOMONAS DIRECT ENZYME IMMUNOASSAY | California Integrated Diagnostics, Inc. | 1987-12-07 | 48 | 0 |
| K871279 | MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | 1987-04-08 | 8 | 0 |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Syncor Intl. Corp. | 1985-08-13 | 50 | 0 |
| K830497 | PEM-T | Hedeco | 1983-04-05 | 48 | 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