Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JPJ · 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) |
|---|---|---|---|---|---|
| K904675 | QBC SYSTEM MCHC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-11-02 | 21 | 0 |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Hycel, Inc. | 1978-07-27 | 48 | 0 |
| K761304 | JTB 700 HEMATOLOGY ANALYZER | J.T. Baker Chemical Co. | 1977-02-01 | 41 | 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