Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MYT · 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) |
|---|---|---|---|---|---|
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | I-Stat Corporation | 2005-12-15 | 197 | 3 |
| K033155 | BIOCENTREX CARDIAC PANEL | Biocentrex | 2004-01-12 | 104 | 0 |
| K984433 | QUANTECH CK-MB ASSAY | Quantech , Ltd. | 1999-11-01 | 322 | 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