Viasys Medsystems: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Viasys Medsystems” (first 2004, latest 2008), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 142 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) | 5 | 5 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
Review panels
Most recent Viasys Medsystems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081725 | ENTERAL PUMP SET, MODEL 20-1010 | KNT | 2008-11-07 | 142 |
| K080679 | MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | KNT | 2008-06-27 | 109 |
| K063061 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | KNT | 2007-04-02 | 179 |
| K043044 | ANTI-I.V. ENTERAL FEEDING SYSTEM | KNT | 2005-05-06 | 183 |
| K050309 | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | CAP | 2005-03-25 | 45 |
| K043004 | STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 | FYA | 2005-03-16 | 135 |
| K041987 | CORTRAK | KNT | 2004-12-17 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Viasys Medsystems.
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.
- Viasys Healthcare GmbH (17 510(k)s)
- Viasys Respiratory Care, Inc. (3 510(k)s)
- Viasys Neuro Care (2 510(k)s)
- Viasys Sleep Systems, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Viasys Medsystems?
FDA lists 7 510(k) clearances under the applicant name “Viasys Medsystems” (first 2004, latest 2008), across 3 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 Viasys Medsystems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viasys Medsystems is 142 days.
Which FDA product codes appear under Viasys Medsystems?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 5); CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 1); FYA (Gown, Surgical, 1).
Next steps
- See all 7 Viasys Medsystems clearances with predicates and recalls
- Run predicate analysis for product code KNT, Viasys Medsystems'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.