Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GQM — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875367 | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV | Enzo Biochem, Inc. | 1988-03-28 | 88 | 0 |
| K810043 | GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I | Vibac Corp. | 1981-05-15 | 128 | 0 |
| K791397 | HERPES EIA TEST KIT | Microbiological Assoc. | 1979-09-24 | 59 | 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