Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PQO — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
346 daysmedian FDA review time
534 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 | 346 | 0 |
| K223679 | Access AMH | Beckman Coulter, Inc. | 2023-02-03 | 57 | 0 |
| K203757 | Elecsys AMH | Roche Diagnostics | 2022-06-10 | 534 | 0 |
| K170524 | Access AMH | Beckman Coulter, Inc. | 2017-11-13 | 264 | 0 |
| DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | 2016-12-19 | 376 | 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