Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GRP · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
140 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884967 | BACTIGEN(R) H. INFLUENZAE TYPE B | Armkel, LLC | 1989-02-07 | 69 | 0 |
| K854490 | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES | American Micro Scan | 1985-12-27 | 45 | 0 |
| K831525 | H-FLU B ELISA TEST | Seragen Diagnostics, Inc. | 1983-09-29 | 140 | 0 |
| K823348 | H. INFLUENZA B ANTISERA FOR CIE | Diagnostica, Inc. | 1982-12-28 | 49 | 0 |
| K821266 | BBL DIRECTIGEN MENINGITIS TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-01 | 29 | 0 |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 | 45 | 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