Orbit Spirometer
by National Biomedical, LLC Dba Qrs Diagnostic
510(k) K120880
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120880 | Date19 Apr 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Orbit
- 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
Overview
AI-generated summary, 20 Sep 2026
The Orbit Spirometer is a diagnostic device classified as a spirometer, designed 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 evaluation of respiratory health and the diagnosis of conditions such as asthma or chronic obstructive pulmonary disease (COPD).
The Orbit Spirometer is intended for use in clinical settings, including hospitals, physician offices, and pulmonary function laboratories. It is a reusable device, supplied sterile or non-sterile depending on the clinical protocol, and adheres to regulatory standards under 21 CFR 868.1840. The device is classified as Class II under special controls and has received FDA 510(k) clearance (K120880). It is not intended for MRI environments and must be stored according to manufacturer instructions to maintain accuracy and functionality.
Questions
AI-generated answers, 20 Sep 2026
What clinical environments is the Orbit Spirometer designed for and how does its reusable nature impact its use?
The Orbit Spirometer is specifically designed for clinical settings such as hospitals, physician offices, and pulmonary function laboratories. Since it is a reusable device, it must be cleaned and maintained according to clinical protocols to ensure hygiene and accuracy. The manufacturer’s instructions should be followed to determine whether it is supplied sterile or non-sterile, as this may vary depending on the intended use and facility protocols.
Can the Orbit Spirometer be used in environments with MRI equipment, and what key considerations should be taken into account?
The Orbit Spirometer is explicitly not intended for use in MRI environments. This restriction is likely due to potential electromagnetic interference or safety concerns related to the presence of magnetic fields. Always ensure the device is used in non-MRI areas to avoid compromising its functionality or patient safety.
How does the Orbit Spirometer measure lung function, and what key parameters does it provide?
The Orbit Spirometer measures lung function by assessing the volume and flow of air inhaled and exhaled. It provides quantitative data on critical respiratory parameters, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). These metrics help clinicians evaluate respiratory health and diagnose conditions like asthma or chronic obstructive pulmonary disease (COPD).
What storage instructions should be followed to maintain the accuracy and functionality of the Orbit Spirometer?
The Orbit Spirometer must be stored according to the manufacturer’s instructions to preserve its accuracy and functionality. While the exact storage conditions are not detailed in the provided data, typical spirometers require protection from extreme temperatures, humidity, and physical damage. Always refer to the manufacturer’s guidelines to ensure optimal performance and longevity.
What regulatory pathway was followed for the Orbit Spirometer’s clearance, and what does this mean for its use in clinical practice?
The Orbit Spirometer received FDA 510(k) clearance (K120880) under a special controls classification, meaning it was determined to be substantially equivalent to a legally marketed device. This clearance indicates that the device meets FDA standards for safety and effectiveness as a diagnostic spirometer. Clinicians can rely on this regulatory approval when integrating the device into their practice, though adherence to manufacturer instructions and clinical protocols remains essential.