Caird Technology Spirometer
510(k) K971336
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971336 | Date1 Dec 1998 | 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- Withdrawn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
- 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, 1 Oct 2026
The Caird Technology Spirometer is a diagnostic device classified as a spirometer, used to measure lung function by assessing airflow and lung volumes. It evaluates respiratory parameters such as forced expiratory volume (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF) to aid in the diagnosis and monitoring of pulmonary conditions. The device provides quantitative data to support clinical assessments of conditions like asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders.
This spirometer is intended for use in clinical settings, including hospitals, physician offices, and pulmonary function laboratories. It is a reusable device, requiring calibration and maintenance as specified by the manufacturer. The device is classified under FDA product code BZG and has received a 510(k) clearance, indicating it is substantially equivalent to a legally marketed predicate device. It is not specified as MRI-safe or sterile, and its regulatory status is tied to the FDA’s 510(k) clearance process.
Other devices from Caird Technology
Questions
AI-generated answers, 1 Oct 2026
What is the Caird Technology Spirometer used for?
The Caird Technology Spirometer is a diagnostic device designed to evaluate lung function by measuring key respiratory parameters such as forced expiratory volume (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF). These measurements help clinicians diagnose and monitor pulmonary conditions like asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders. The device provides quantitative data to support clinical assessments in settings such as hospitals, physician offices, and pulmonary function labs.
Is the Caird Technology Spirometer reusable or single-use?
The Caird Technology Spirometer is a reusable device. Like other reusable medical instruments, it requires regular calibration and maintenance as outlined by the manufacturer to ensure accurate and reliable performance. Proper cleaning and upkeep are essential to prevent contamination and maintain diagnostic precision over time.
What regulatory approval does the Caird Technology Spirometer hold?
The Caird Technology Spirometer has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance is tied to the FDA’s 510(k) process and indicates that the device meets regulatory standards for safety and effectiveness as a diagnostic spirometer. The device is classified under FDA product code BZG.
How is the Caird Technology Spirometer supplied, and what should be considered for storage?
The Caird Technology Spirometer is supplied as a reusable clinical device, meaning it is intended for repeated use in healthcare settings. Since it is not specified as sterile, proper cleaning and disinfection protocols must be followed between uses to maintain hygiene. Storage should be in a clean, dry environment, protected from physical damage and extreme temperatures, to preserve its functionality and calibration accuracy.
Does the Caird Technology Spirometer have any special safety considerations, such as MRI compatibility?
The Caird Technology Spirometer is not specified as MRI-safe in its documentation. Clinicians should ensure the device is not exposed to MRI environments unless verified otherwise by the manufacturer. Additionally, since it is a reusable device, adherence to manufacturer guidelines for calibration, maintenance, and cleaning is critical to ensure safe and accurate operation.