Winfield Co., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Winfield Co., Inc.” (first 1980, latest 1994), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 144 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
Most recent Winfield Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942902 | SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER | MMK | 1994-12-15 | 231 |
| K942903 | SHARPS-TAINER SMALL OPENING | FMI | 1994-09-19 | 144 |
| K942901 | SHARPS-TAINER LARGE OPENING | FMI | 1994-09-19 | 144 |
| K891855 | WINFIELD LATEX EXAMINATION GLOVES | LYY | 1989-06-22 | 87 |
| K802803 | CONVALESCENT RECLINER | INO | 1980-11-19 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Winfield Co., 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.
- Winfield Laboratories, Inc. (4 510(k)s)
- Winfield Industries (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Winfield Co., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Winfield Co., Inc.” (first 1980, latest 1994), across 4 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 Winfield Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Winfield Co., Inc. is 144 days.
Which FDA product codes appear under Winfield Co., Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); INO (Chair, Positioning, Electric, 1); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 5 Winfield Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Winfield Co., 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.