VIP Pulmonary Function System
510(k) K080510
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080510 | Date20 Aug 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1890
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The VIP Pulmonary Function System is a predicted values calculator for pulmonary function testing, classified under FDA regulation 868.1890 as a Class II device. It is designed to assist in the assessment of lung function by generating predicted reference values for spirometry and other respiratory measurements in both pediatric and adult patients. This system aids clinicians in diagnosing conditions such as obstructive or restrictive lung diseases, evaluating disability claims, and differentiating between cardiac and pulmonary causes of symptoms.
This device is intended for use in clinical settings, including hospitals, pulmonary function laboratories, and outpatient care facilities. It operates as a non-sterile, reusable system, requiring no special storage conditions beyond standard environmental parameters. The system is not MRI-safe and must be used in non-magnetic environments. Authorized under FDA 510(k) clearance (K080510) with a Special review classification, it adheres to regulatory standards for pulmonary function testing devices. No additional sterilization or single-use requirements are specified.
Other devices from Viasys Healthcare GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the VIP Pulmonary Function System used for?
The VIP Pulmonary Function System is designed to assist clinicians in assessing lung function by generating predicted reference values for spirometry and other respiratory measurements. This helps in diagnosing conditions such as obstructive or restrictive lung diseases, evaluating disability claims, and distinguishing between cardiac and pulmonary causes of symptoms. It is specifically intended for use in clinical settings like hospitals, pulmonary function laboratories, and outpatient care facilities.
Is the VIP Pulmonary Function System reusable or single-use?
The VIP Pulmonary Function System is a non-sterile, reusable device. It does not require sterilization between uses and can be utilized repeatedly in clinical settings without additional processing. Standard environmental storage conditions are sufficient for maintaining its functionality.
What storage conditions are required for the VIP Pulmonary Function System?
The system does not have special storage requirements beyond standard environmental parameters. It should be stored in a clean, dry environment, away from sources of magnetic interference, as it is not MRI-safe and must be used in non-magnetic settings.
Does the VIP Pulmonary Function System cover pediatric and adult patients?
Yes, the VIP Pulmonary Function System is designed to generate predicted reference values for both pediatric and adult patients. This versatility allows clinicians to accurately assess lung function across a wide range of patient ages, supporting comprehensive diagnostic evaluations.
What regulatory clearance does the VIP Pulmonary Function System hold?
The VIP Pulmonary Function System holds FDA 510(k) clearance under the classification K080510, with a Special review classification. It adheres to regulatory standards for pulmonary function testing devices as outlined under FDA regulation 868.1890, ensuring compliance with safety and performance requirements.