Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioenterics Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002838 | GASTRIC SUCTION AND DRAINAGE CATHETER | Bioenterics Corp. | 2001-07-09 | 300 | 0 |
| K964561 | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5 | Bioenterics Corp. | 1997-02-11 | 90 | 0 |
| K934084 | BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE | Bioenterics Corp. | 1993-12-16 | 118 | 0 |
| K924753 | BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE | Bioenterics Corp. | 1992-12-15 | 84 | 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