Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GRO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851271 | LEGIONELLA CULTURE CONFIRMATIN KIT | Gen-Probe, Inc. | 1985-07-08 | 98 | 0 |
| K834067 | LEGIONELLA DIFFERENTIATION DISK | Remel Co. | 1984-01-03 | 39 | 0 |
| K802423 | PHADEBACT HAEMOPHILUS TEST | Pharmacia, Inc. | 1980-11-12 | 40 | 0 |
| K800493 | BACTOGEN-H. INFLUENZAE TYPE B | Armkel, LLC | 1980-04-04 | 31 | 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