Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Diagnostic Medical Systems, 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) |
|---|---|---|---|---|---|
| K882746 | ADMS SILENT NEEDLE GUN | Advanced Diagnostic Medical Systems, Inc. | 1989-03-17 | 255 | 0 |
| K890203 | ADMS BIOPSY NEEDLE | Advanced Diagnostic Medical Systems, Inc. | 1989-03-08 | 50 | 0 |
| K881208 | PROBE SHEATH FOR ADMS ULTRASOUND PROBE | Advanced Diagnostic Medical Systems, Inc. | 1988-05-16 | 56 | 0 |
| K875119 | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | Advanced Diagnostic Medical Systems, Inc. | 1988-03-02 | 78 | 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