Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Entech, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
147 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891371 | GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG | Entech, Inc. | 1989-08-03 | 147 | 0 |
| K890430 | ENTAINER(TM) ENTERAL FEEDING CONTAINER | Entech, Inc. | 1989-06-02 | 127 | 0 |
| K873343 | ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM | Entech, Inc. | 1987-12-07 | 110 | 0 |
| K873444 | ENTECH ENTERAL PUMP AND SET | Entech, Inc. | 1987-11-02 | 67 | 0 |
| K871019 | ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET | Entech, Inc. | 1987-06-09 | 85 | 0 |
| K861427 | ENTUBE TM, ENTERAL FEEDING TUBE | Entech, Inc. | 1986-07-18 | 93 | 0 |
| K861552 | TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS | Entech, Inc. | 1986-06-16 | 52 | 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