Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ENW · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851082 | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | American V. Mueller | 1985-07-22 | 126 | 0 |
| K832476 | SILICONE SOFT-PAK EPISTAXIS CATHETER | Axiom Medical, Inc. | 1983-11-03 | 100 | 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