Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hemedex Incorporated — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141869 | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | Hemedex Incorporated | 2014-10-10 | 91 | 0 |
| K032127 | HEMEDEX FIXATION DEVICE | Hemedex Incorporated | 2003-12-30 | 173 | 0 |
| K032337 | HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 | Hemedex Incorporated | 2003-10-21 | 84 | 0 |
| K013376 | QFLOW 500 PERFUSION MONITORING SYSTEM | Hemedex Incorporated | 2002-05-08 | 209 | 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