# Viasys Healthcare GmbH

- Location (FDA's records): Hoechberg, DE
- FDA decisions: 17 (2003–2009): 17 510(k) clearances
- Names in FDA's records: Viasys Healthcare GmbH (14); Viasys Healthcare, Inc. (3)
- Product codes: BTY (5), BZC (2), DQA (2), DPS (1), EWO (1), IYN (1), BZH (1), GZK (1), JEH (1), CCM (1), DSH (1)
- Predicates its devices cite: 22 (4 its own); citations of its devices by later devices: 19 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Grason-Stadler, Inc.: 2 (https://510kreport.com/company/grason-stadler)
- Lucas Grason-Stadler, Inc.: 2 (https://510kreport.com/company/lucas-grason-stadler)
- Cardinal Health Germany 234 GmbH: 2 (https://510kreport.com/company/cardinal-health-germany-234)
- Erich Jaeger, Inc.: 2 (https://510kreport.com/company/erich-jaeger)
- H&C Medical Devices Spa: 1 (https://510kreport.com/company/h-c-medical-devices)
- Everest Biomedical Instruments Co.: 1 (https://510kreport.com/company/everest-biomedical-instruments)
- Compumedics Germany Gmgh: 1 (https://510kreport.com/company/compumedics-germany-gmgh)
- Spencer Technologies: 1 (https://510kreport.com/company/spencer-technologies)

## Firms that cite its devices most
- Carefusion Germany 234 GmbH: 7 (https://510kreport.com/company/carefusion-germany-234)
- Cardinal Health Germany 234 GmbH: 2 (https://510kreport.com/company/cardinal-health-germany-234)
- Viasonix, Ltd.: 1 (https://510kreport.com/company/viasonix)
- Ganshorn Medizin Electronic GmbH: 1 (https://510kreport.com/company/ganshorn-medizin-electronic)
- Intelligent Hearing Systems: 1 (https://510kreport.com/company/intelligent-hearing-systems)
- Vitalograph (Ireland), Ltd.: 1 (https://510kreport.com/company/vitalograph-ireland)
- Guangzhou Homesun Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-homesun-medical-technology)
- Dyansys, Inc.: 1 (https://510kreport.com/company/dyansys)

## Its most-cited devices
- K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body (2008), cited by 4
- K071753: Masterscreen Pneumo & Masterscope (2007), cited by 3
- K092324: Spiropro (2009), cited by 3
- K070614: Corscreen (2007), cited by 2
- K031713: Audiometer, Otoacoustic Emission, Auditory Branstem Response Access (2003), cited by 1
- K060421: Sonara; Sonara/Tek (2006), cited by 1

## Recent decisions
- K092324: Spiropro (Sep 3, 2009)
- K091412: Clean Peak Flow Meter (Aug 21, 2009)
- K091505: COR12+ (Jun 10, 2009)
- K081823: Masterscreen Paed - Baby Body (May 18, 2009)
- K080510: Vip Pulmonary Function System (Aug 20, 2008)
- K080734: Flowscreen, Flowscreen/Corscreen, Flowscreen CT (Jun 26, 2008)
- K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body (Apr 22, 2008)
- K072323: Masterscreen & Oxycon CPX (Oct 10, 2007)

Source page: https://510kreport.com/company/viasys-healthcare