Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KSZ — 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) |
|---|---|---|---|---|---|
| K810899 | TECHNICON AUTOGROUPER 16-C SYSTEM | Technicon Instruments Corp. | 1981-05-05 | 32 | 0 |
| K790282 | ELDONCARD | Nordisk Infuser System | 1979-05-04 | 80 | 0 |
| K771098 | BLOOD GROUPING SYS., BG-9 | Technicon Instruments Corp. | 1977-08-04 | 45 | 0 |
| K770185 | RH CONTROL DILUENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-14 | 46 | 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