Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QIS — 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) |
|---|---|---|---|---|---|
| K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | 2024-09-06 | 266 | 0 |
| K230056 | MiVu™ Esophageal Endo Cap | Diversatek Healthcare | 2023-04-25 | 106 | 0 |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | Diversatek Healthcare, Inc. | 2019-12-23 | 371 | 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