Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance Db Data Managementsoftware
by Puritan Bennett Corp. 510(k)
Active
510(k) K944762
Overview
The Puritan-Bennett Renaissance Spirometry System is a diagnostic device classified as a spirometer, designed to measure lung function parameters such as forced vital capacity, forced expiratory volume, and peak expiratory flow. It provides objective data for assessing respiratory health, monitoring chronic conditions like asthma or COPD, and evaluating patient responses to treatment.
This system is intended for use in clinical settings, including hospitals and physician offices, and operates as a reusable medical device. It includes optional Renaissance DB software for data management, ensuring compliance with regulatory standards as evidenced by its FDA 510(k) clearance under product code BZG. The device is intended for single-use measurements per session, with calibration and maintenance requirements specified in its operational manual.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944762 | Date13 Dec 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What clinical measurements does the Renaissance Spirometry System provide, and how are these useful in patient care?
The Renaissance Spirometry System measures key lung function parameters such as forced vital capacity (FVC), forced expiratory volume (FEV), and peak expiratory flow. These metrics are critical for assessing respiratory health, diagnosing conditions like asthma or COPD, and monitoring patient responses to treatments over time. The objective data it provides helps clinicians make informed decisions about treatment plans and disease progression.
Is the Renaissance Spirometry System designed for single-use or reusable applications, and what does this mean for maintenance?
The Renaissance Spirometry System is explicitly designed as a reusable medical device, meaning it is intended for multiple use sessions. However, it is intended for single-use measurements per session, implying that each patient interaction requires a fresh setup or calibration. Maintenance requirements, including calibration and cleaning, are detailed in the operational manual to ensure accuracy and compliance with regulatory standards.
What software options are available with the Renaissance Spirometry System, and how does it support clinical workflows?
The Renaissance Spirometry System includes an optional Renaissance DB Data Management Software, which facilitates the collection, storage, and analysis of spirometry results. This software helps streamline clinical workflows by enabling compliance tracking, patient data organization, and reporting—key features for respiratory care settings like hospitals and physician offices.
How is the Renaissance Spirometry System regulated, and what does this mean for healthcare providers?
The Renaissance Spirometry System holds an FDA 510(k) clearance under product code BZG, classified as substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a diagnostic spirometer. For healthcare providers, this clearance ensures the device adheres to regulatory requirements for use in clinical settings, though it does not imply any specific clinical indication beyond its intended purpose as described in the data.
Are there different models or sizes available for the Renaissance Spirometry System, and how might this affect its use?
The provided data does not specify distinct models or sizes for the Renaissance Spirometry System, implying it is likely offered as a single, standardized device. However, its design as a reusable spirometer suggests adaptability for various clinical environments, including hospitals and physician offices. If specific configurations (e.g., portability or additional accessories) are needed, they would be addressed in the operational manual or supplementary documentation.