Winmed Instruments Mfg. Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Winmed Instruments Mfg. Corp.” (first 1989, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 102 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
- General Hospital (4)
- Cardiovascular (1)
Most recent Winmed Instruments Mfg. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942163 | WINNER SELF-TAKING HOME BLOOD PRESSURE KIT | DXN | 1994-12-20 | 230 |
| K892079 | CHAMP-PAQ VINYL PATIENT EXAM GLOVES | LYZ | 1989-09-01 | 151 |
| K892097 | CHAMP-PAQ LATEX PATIENT EXAM GLOVES | LYY | 1989-07-14 | 102 |
| K893107 | CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES | LYY | 1989-06-19 | 66 |
| K892098 | CHAMP-PAQ VINYL PATIENT EXAM GLOVES | LYZ | 1989-04-28 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Winmed Instruments Mfg. Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Winmed Instruments Mfg. Corp.?
FDA lists 5 510(k) clearances under the applicant name “Winmed Instruments Mfg. Corp.” (first 1989, latest 1994), across 3 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 Winmed Instruments Mfg. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Winmed Instruments Mfg. Corp. is 102 days.
Which FDA product codes appear under Winmed Instruments Mfg. Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 2); LYZ (Vinyl Patient Examination Glove, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 5 Winmed Instruments Mfg. Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Winmed Instruments Mfg. Corp.'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.