Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KJB · 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) |
|---|---|---|---|---|---|
| K881466 | CELL-CULTURE SHAKER | Cryodyne Technologies, Inc. | 1988-04-18 | 12 | 0 |
| K872076 | CORNING DISPOSABLE ROLLER BOTTLES | Corning Medical & Scientific | 1987-06-15 | 17 | 0 |
| K852506 | BIOGLAS MICROCARRIER BEAD | Solohill Engineering, Inc. | 1985-07-12 | 30 | 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