Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KCF · 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) |
|---|---|---|---|---|---|
| K962688 | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE | Boston Medical Products, Inc. | 1996-07-25 | 14 | 0 |
| K923355 | PHARYNGEAL SALIVARY BYPASS TUBE | Boston Medical Products, Inc. | 1992-10-06 | 90 | 0 |
| K812305 | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE | Boston Medical Products, Inc. | 1981-09-08 | 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