Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QPS · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230944 | MeMed BV | MeMed Diagnostics, Ltd. | 2023-06-30 | 87 | 0 |
| K222332 | MeMed BV | MeMed Diagnostics, Ltd. | 2023-03-23 | 233 | 0 |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | DiaSorin, Inc. | 2022-07-14 | 210 | 0 |
| K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021-09-01 | 215 | 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