Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ekf-Diagnostic GmbH — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
354 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | 2020-06-12 | 67 | 0 |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019-02-16 | 354 | 0 |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | 2018-04-06 | 261 | 0 |
| K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; | Ekf-Diagnostic GmbH | 2011-03-04 | 21 | 0 |
| K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | Ekf Diagnostic GmbH | 2003-09-24 | 97 | 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