Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JBR · 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) |
|---|---|---|---|---|---|
| K925452 | DADE HEPZYME | Baxter Diagnostics, Inc. | 1993-01-11 | 75 | 0 |
| K874373 | PT PRO-CLOT | Probe-Tek, Inc. | 1988-01-05 | 71 | 0 |
| K770722 | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | Bay Area Hema. Onco. Clinic. & Res. L | 1977-07-11 | 83 | 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