Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NRF · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042750 | QC-BEADS | Bioscreen, Inc. | 2004-10-29 | 25 | 0 |
| K041600 | QWIKCHECK-BEADS | Medical Electronics Systems , Ltd. | 2004-07-27 | 43 | 0 |
| K041240 | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED | Fertility Solutions, Inc. | 2004-06-02 | 22 | 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