Entech, Inc.: FDA clearances and approvals
Entech, Inc. has 7 FDA 510(k) clearances (first 1986, latest 1989), across 2 product codes in 2 review panels. Median 510(k) review time: 93 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 6 | 6 |
| FRN | Pump, Infusion | 1 | 1 |
Review panels
Most recent Entech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891371 | GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG | KNT | 1989-08-03 | 147 |
| K890430 | ENTAINER(TM) ENTERAL FEEDING CONTAINER | KNT | 1989-06-02 | 127 |
| K873343 | ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM | KNT | 1987-12-07 | 110 |
| K873444 | ENTECH ENTERAL PUMP AND SET | FRN | 1987-11-02 | 67 |
| K871019 | ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET | KNT | 1987-06-09 | 85 |
| K861427 | ENTUBE TM, ENTERAL FEEDING TUBE | KNT | 1986-07-18 | 93 |
| K861552 | TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS | KNT | 1986-06-16 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Entech, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Entech, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Entech, Inc. have?
Entech, Inc. has 7 FDA 510(k) clearances (first 1986, latest 1989), across 2 product codes in 2 review panels.
How long does FDA take to clear Entech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Entech, Inc.'s cleared 510(k)s is 93 days.
What devices does Entech, Inc. make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 6); FRN (Pump, Infusion, 1).
Has Entech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Entech, Inc. Related entities may recall under other names.
Next steps
- See all 7 Entech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Entech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.