Q101 Diagnostic Spirometer
by Quinton, Inc. 510(k)
Active
510(k) K863300
Overview
The Q101 Diagnostic Spirometer is a Diagnostic Spirometer (Product Code: BYT) designed to measure lung function by assessing airflow and lung volumes. It evaluates parameters such as forced vital capacity (FVC), forced expiratory volume in one second (FEV₁), and peak expiratory flow (PEF) to aid in the diagnosis and monitoring of respiratory conditions.
This device is intended for use in clinical settings, including pulmonary function laboratories and physician offices, and is classified as a Class II medical device under FDA regulations. Supplied as a reusable instrument, it requires proper calibration and maintenance to ensure accurate readings. The Q101 holds FDA 510(k) clearance (K863300) and is regulated under the Negative Pressure Ventilator category (Regulation Number: 868.5935) for adult use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863300 | Date13 Nov 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BYT
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5935
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What clinical parameters does the Q101 Diagnostic Spirometer measure, and how are these used in patient care?
The Q101 Diagnostic Spirometer measures key lung function parameters such as forced vital capacity (FVC), forced expiratory volume in one second (FEV₁), and peak expiratory flow (PEF). These metrics help clinicians diagnose and monitor respiratory conditions by assessing airflow obstruction, lung volume restrictions, and overall pulmonary function. For example, low FEV₁ values may indicate asthma or chronic obstructive pulmonary disease (COPD), while declining PEF trends can signal worsening airway resistance over time.
Is the Q101 Diagnostic Spirometer intended for single-use or reusable applications, and what maintenance is required?
The Q101 is designed as a reusable instrument, meaning it must be properly cleaned, calibrated, and maintained between uses to ensure accurate and reliable readings. Since it is classified as a reusable Class II device, facilities must follow manufacturer guidelines for disinfection and periodic calibration to prevent drift in measurements, which could compromise diagnostic accuracy.
What types of clinical settings is the Q101 intended for, and how does its regulatory classification support its use?
The Q101 is explicitly intended for clinical settings, including pulmonary function laboratories and physician offices, where precise lung function assessments are performed. Its classification as a Class II medical device under FDA regulations (with 510(k) clearance via K863300) ensures it meets stringent performance standards for diagnostic accuracy. The device’s regulatory route—substantially equivalent to a predicate—confirms its compliance with safety and effectiveness requirements for routine respiratory diagnostics.
How does the Q101’s regulatory history (e.g., advisory committee involvement) influence its credibility or clinical adoption?
The Q101’s regulatory pathway involved review by the Anesthesiology (AN) Advisory Committee, which evaluates devices related to respiratory function and ventilation. While this committee’s role was advisory (not decision-making), its engagement underscores the device’s relevance to pulmonary diagnostics. Clinicians may view this involvement as a positive indicator of rigorous pre-market scrutiny, though the actual clearance was granted via a traditional 510(k) pathway based on substantial equivalence to prior devices.