Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Diagnostics, 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) |
|---|---|---|---|---|---|
| K023037 | MID STREAM PREGNANCY TEST | Advanced Diagnostics, Inc. | 2003-04-09 | 209 | 0 |
| K013886 | AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | Advanced Diagnostics, Inc. | 2002-05-10 | 168 | 0 |
| K013291 | ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) | Advanced Diagnostics, Inc. | 2001-11-14 | 43 | 0 |
| K001510 | OS-2000 OPTICAL SONOGRAPHY SYSTEM | Advanced Diagnostics, Inc. | 2000-11-30 | 199 | 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