Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PTC · 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) |
|---|---|---|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. | 2025-04-04 | 249 | 0 |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid | Taidoc Technology Corporation | 2018-12-10 | 168 | 0 |
| K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | 2017-04-11 | 368 | 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