FlowMate II Plus, Model #4000
by Spirometrics Medical Equipment Co. 510(k)
Active
510(k) K982956
Overview
The FlowMate II Plus, Model #4000 is a diagnostic spirometer, a device used to measure lung function by assessing the volume and flow of air inhaled and exhaled. It provides quantitative data on parameters such as forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF), aiding in the diagnosis and monitoring of respiratory conditions. This device is classified under the FDA’s product code BZG and falls within Class II medical devices, requiring special controls to ensure safety and effectiveness.
The FlowMate II Plus, Model #4000 is intended for use in clinical settings, such as hospitals, physician offices, and pulmonary function laboratories. It is designed for single-use or reusable applications, depending on manufacturer guidelines, and must be maintained according to regulatory standards. The device holds FDA 510(k) clearance (K982956) under the Anesthesiology advisory committee, with a regulatory classification of Class II. Storage and handling should comply with manufacturer instructions to preserve accuracy and sterility, though specific sterility claims are not provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982956 | Date24 Nov 1998 | 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- Withdrawn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 Spirometrics Medical Equipment Co.
Questions
What is the FlowMate II Plus Model 4000 used for?
The FlowMate II Plus Model 4000 is a diagnostic spirometer designed to measure lung function by evaluating the volume and flow of inhaled and exhaled air. It provides quantitative data on key parameters like forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). These measurements help clinicians diagnose and monitor respiratory conditions such as asthma, COPD, and other pulmonary disorders in clinical settings like hospitals, physician offices, and pulmonary labs.
Is the FlowMate II Plus Model 4000 single-use or reusable?
The FlowMate II Plus Model 4000 can be used either as a single-use device or as a reusable device, depending on the manufacturer’s guidelines and the specific clinical protocol in place. If reused, it must be cleaned, disinfected, and maintained according to regulatory standards to ensure accuracy and safety. Always follow the manufacturer’s instructions for proper handling and reprocessing to avoid contamination or performance degradation.
Does the FlowMate II Plus Model 4000 come with sterility guarantees?
The provided data does not explicitly state that the FlowMate II Plus Model 4000 is sterile upon packaging or delivery. If sterility is required for a procedure, it must be achieved through manufacturer-specified sterilization processes (e.g., autoclaving, chemical sterilization) before first use. Always verify the sterility status and follow the manufacturer’s instructions for proper preparation and storage to maintain device integrity.
What regulatory approval does the FlowMate II Plus Model 4000 hold?
The FlowMate II Plus Model 4000 holds FDA 510(k) clearance under the product code BZG, classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and received clearance through the Anesthesiology advisory committee. The clearance number is K982956, and it was filed under the regulation number 868.1840. This classification ensures it meets special controls for safety and effectiveness as required by the FDA.
How should the FlowMate II Plus Model 4000 be stored?
The FlowMate II Plus Model 4000 should be stored in a clean, dry environment, protected from extreme temperatures, humidity, and direct sunlight to preserve its accuracy and functionality. If the device is reusable, follow the manufacturer’s guidelines for cleaning, disinfection, and maintenance between uses. Proper storage conditions help prevent damage to components and ensure reliable performance when needed for clinical assessments.