Med-West, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Med-West, Inc.” (first 1983, latest 1988), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| FIQ | Cannula, A-V Shunt | 2 | 2 |
| LFK | Catheter, Femoral | 2 | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| LFJ | Catheter, Subclavian | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (5)
- Cardiovascular (2)
- General Hospital (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Med-West, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880877 | CONTRAST INJECTION DEVICE | DXT | 1988-05-31 | 91 |
| K880398 | POWER TOILET ELEVATOR | INO | 1988-03-17 | 48 |
| K874470 | MWI 400 WOUND DRESSING | NAD | 1987-12-18 | 46 |
| K872724 | SHEATH/DILATORS | DRE | 1987-09-15 | 69 |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | LFK | 1986-01-03 | 46 |
| K852162 | MNI 400 INJECTION CAPS | LFJ | 1985-06-12 | 23 |
| K842342 | MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN | — | 1984-06-14 | 0 |
| K832124 | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | DWF | 1983-08-12 | 43 |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | LFK | 1983-07-07 | 30 |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | FIQ | 1983-06-03 | 29 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Med-West, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Med-West, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Med-West, Inc.” (first 1983, latest 1988), across 9 product codes in 5 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 Med-West, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-West, Inc. is 43 days.
Which FDA product codes appear under Med-West, Inc.?
The most frequent FDA product codes under this applicant name are FIQ (Cannula, A-V Shunt, 2); LFK (Catheter, Femoral, 2); DRE (Dilator, Vessel, For Percutaneous Catheterization, 1).
Next steps
- See all 11 Med-West, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIQ, Med-West, 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.