Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FCY · 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) |
|---|---|---|---|---|---|
| K093718 | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 | Zutron Medical, LLC | 2010-02-22 | 82 | 0 |
| K904376 | ANEROID BLOOD PRESSURE GAUGE | Biomedical Dynamics, Inc. | 1990-12-20 | 86 | 0 |
| K900016 | TRANS/R - FP(3) | CIVCO Medical Instruments Co., Inc. | 1990-06-11 | 160 | 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