Voss Medical Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Voss Medical Products” (first 1989, latest 1993), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| KIL | Positioner, Socket | 1 | 1 |
| KPK | Marker, Ostia, Aorto-Saphenous Vein | 1 | 1 |
Review panels
Most recent Voss Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932187 | PRONE POSITIONER | KIL | 1993-06-01 | 27 |
| K932186 | BYPASS LEG POSITIONER | FQO | 1993-06-01 | 27 |
| K896338 | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA | DWF | 1990-05-17 | 195 |
| K885161 | VOSS VEIN CLAMP | DXC | 1989-12-22 | 374 |
| K895369 | VOSS GRAFT MARKER | KPK | 1989-09-27 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Voss Medical Products.
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.
- Voss Products (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Voss Medical Products?
FDA lists 5 510(k) clearances under the applicant name “Voss Medical Products” (first 1989, latest 1993), across 5 product codes in 3 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 Voss Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Voss Medical Products is 29 days.
Which FDA product codes appear under Voss Medical Products?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1); DXC (Clamp, Vascular, 1); FQO (Table, Operating-Room, Ac-Powered, 1).
Next steps
- See all 5 Voss Medical Products clearances with predicates and recalls
- Run predicate analysis for product code DWF, Voss Medical Products'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.