Viasys Healthcare GmbH: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Viasys Healthcare GmbH” (first 2003, latest 2009), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | 5 | 5 |
| BZC | Calculator, Pulmonary Function Data | 2 | 2 |
| DQA | Oximeter | 2 | 2 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
| CCM | Plethysmograph, Pressure | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GZK | Electrode, Nasopharyngeal | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (12)
- Cardiovascular (2)
- Ear, Nose and Throat (1)
- Neurology (1)
- Radiology (1)
Most recent Viasys Healthcare GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092324 | SPIROPRO | DQA | 2009-09-03 | 30 |
| K091412 | CLEAN PEAK FLOW METER | BZH | 2009-08-21 | 100 |
| K091505 | COR12+ | DSH | 2009-06-10 | 20 |
| K081823 | MASTERSCREEN PAED - BABY BODY | CCM | 2009-05-18 | 325 |
| K080510 | VIP PULMONARY FUNCTION SYSTEM | BTY | 2008-08-20 | 177 |
| K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | BTY | 2008-06-26 | 104 |
| K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | JEH | 2008-04-22 | 270 |
| K072323 | MASTERSCREEN & OXYCON CPX | BZC | 2007-10-10 | 51 |
| K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | BTY | 2007-08-14 | 47 |
| K062011 | MODIFICATION TO FLOWSCREEN | BTY | 2007-05-11 | 298 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Viasys Healthcare GmbH.
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 Medsystems (7 510(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 Healthcare GmbH?
FDA lists 17 510(k) clearances under the applicant name “Viasys Healthcare GmbH” (first 2003, latest 2009), across 11 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 Viasys Healthcare GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viasys Healthcare GmbH is 104 days.
Which FDA product codes appear under Viasys Healthcare GmbH?
The most frequent FDA product codes under this applicant name are BTY (Calculator, Predicted Values, Pulmonary Function, 5); BZC (Calculator, Pulmonary Function Data, 2); DQA (Oximeter, 2).
Next steps
- See all 17 Viasys Healthcare GmbH clearances with predicates and recalls
- Run predicate analysis for product code BTY, Viasys Healthcare GmbH'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.