Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZS — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
56 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933123 | SYNELISA TG ANTIBODIES/TPO ANTIBODIES | Elias U.S.A., Inc. | 1993-08-23 | 56 | 0 |
| K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | American Scientific Products | 1981-08-31 | 28 | 0 |
| K770566 | IMMUNOELECTROPHORESIS PROFILE KIT | Kallestad Laboratories, Inc. | 1977-04-27 | 34 | 0 |
| K770718 | STAIN, R-250, COOMASSIE BRILLIANT BLUE | Kallestad Laboratories, Inc. | 1977-04-26 | 8 | 0 |
| K770719 | IMMUNOELECTROFILM KIH | Kallestad Laboratories, Inc. | 1977-04-26 | 8 | 0 |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Millipore Corp. | 1977-02-01 | 8 | 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