Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JKM — 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) |
|---|---|---|---|---|---|
| K080916 | CAPILLARYS URINE | Sebia | 2008-07-01 | 90 | 0 |
| K070486 | CAPILLARYS URINE (PN 2012) | Sebia, Inc. | 2007-12-21 | 304 | 0 |
| K050119 | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE | Beckman Coulter, Inc. | 2005-05-06 | 108 | 0 |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRA | Morax | 1998-03-04 | 236 | 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