Norwich Eaton Pharmaceuticals, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Norwich Eaton Pharmaceuticals, Inc.” (first 1980, latest 1984), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 30 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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) | 9 | 9 |
| KHT | Fraction V, Antigen, Antiserum, Control | 1 | 1 |
Review panels
Most recent Norwich Eaton Pharmaceuticals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842841 | VIVONEX TUNG STEN TIP TUBE | KNT | 1984-08-14 | 25 |
| K831971 | VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE | KNT | 1983-09-01 | 73 |
| K831969 | VIVONEX TUNGSTEN TIP TUBE-WOUND | KNT | 1983-09-01 | 73 |
| K831968 | VIVONEX TUNGSTEN TIP TUBE-BRAIDED | KNT | 1983-09-01 | 73 |
| K831970 | VIVONEX TUNGSTEN TIP TUBE-MONOFILA- | KNT | 1983-07-18 | 28 |
| K822516 | VIVONEX MASS GASTRASTOMY TUBE | KHT | 1982-09-07 | 18 |
| K821231 | VIVONEX TUNGSTEN TIP TUBE PLACEMENT | KNT | 1982-05-10 | 13 |
| K821067 | VIVONEX ACUTROL ENTERNAL FEEDING SYS | KNT | 1982-04-29 | 13 |
| K811968 | VIVONEX TUNGSTEN TIP | KNT | 1981-08-25 | 46 |
| K802300 | VIVONEX JEJUNOSTOMY KIT | KNT | 1980-10-23 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Norwich Eaton Pharmaceuticals, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Norwich Pharmacal Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Norwich Eaton Pharmaceuticals, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Norwich Eaton Pharmaceuticals, Inc.” (first 1980, latest 1984), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Norwich Eaton Pharmaceuticals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Norwich Eaton Pharmaceuticals, Inc. is 30 days.
Which FDA product codes appear under Norwich Eaton Pharmaceuticals, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 9); KHT (Fraction V, Antigen, Antiserum, Control, 1).
Next steps
- See all 10 Norwich Eaton Pharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Norwich Eaton Pharmaceuticals, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.