Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Devices, Inc. · 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) |
|---|---|---|---|---|---|
| K090307 | DDI ULTRASONIC NEBULIZER SYSTEM | Diagnostic Devices, Inc. | 2009-06-18 | 132 | 0 |
| K073118 | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM | Diagnostic Devices, Inc. | 2008-03-05 | 121 | 0 |
| K060467 | PRODIGY BLOOD GLUCOSE TEST SYSTEM | Diagnostic Devices, Inc. | 2006-07-13 | 140 | 0 |
| K053593 | PRODIGY | Diagnostic Devices, Inc. | 2006-07-06 | 195 | 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