Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJD · 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) |
|---|---|---|---|---|---|
| K123805 | E-Z CHEK BLOOD LEAK TEST STRIPS | Reprocessing Products Corp | 2013-03-20 | 99 | 0 |
| K042322 | STERICHEK BLOOD LEAK REAGENT STRIPS | Hach Company | 2004-12-07 | 103 | 0 |
| K012115 | SERIM BLOOD LEAK TEST STRIP-2 | Serim Research Corp. | 2001-11-30 | 147 | 0 |
| K990206 | SERIM BLOOD LEAK TEST STRIP | Serim Research Corp. | 1999-04-21 | 90 | 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