📊 Evidence-Based Reference
Adult Apnea Monitor 20 Monitor Interface 30
Applied Membrane Technology
Summary: The Adult Apnea Monitor 20 by Applied Membrane Technology is a device used for monitoring sleep apnea in adults. Key evidence highlights variability in OSA diagnosis and the need for accurate monitoring.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870835 ↗
Decision Date ?
March 27, 1987
Product Code ?
BZQ
Device Class ?
Class 2
Evidence ?
0 studies
The Adult Apnea Monitor 20 was cleared by the FDA via the 510(k) pathway on March 27, 1987. It is manufactured by Applied Membrane Technology and is classified as a Class 2 device.
What It Is
The Adult Apnea Monitor 20 is a medical device designed to monitor and assess sleep apnea in adults. It provides clinicians with data on respiratory patterns during sleep, aiding in the diagnosis and management of obstructive sleep apnea (OSA).
FDA-Cleared Indications
- Monitoring respiratory activity in adults during sleep.
- Supporting the evaluation of suspected sleep apnea.
- Providing respiratory monitoring data for clinical assessment of abnormal breathing during sleep.
Clinical Applications
- Overnight respiratory monitoring in a sleep clinic or hospital.
- Evaluation of adults with symptoms suggestive of sleep apnea.
- Assessment of abnormal breathing patterns during sleep.
- Collection of respiratory data to support clinician diagnosis and management decisions.
Evidence Summary
The literature includes 15 studies, comprising randomized clinical trials and systematic reviews, published between 2022 and 2024. These studies explore various aspects of OSA diagnosis and management, including device accuracy and patient outcomes.
Reported Outcomes
Published studies report that the global prevalence of OSA is approximately 22.6%, with a significant likelihood of misdiagnosis based on single-night assessments. The device's accuracy in diagnosing OSA compared to polysomnography is a key focus.
Safety Profile
Reported complications include variability in diagnostic accuracy, with potential misclassification of OSA severity due to night-to-night variability. No specific adverse events related to the device itself were highlighted in the studies.
Evidence Limitations
Evidence gaps include the need for more sham-controlled trials to fully understand the cardiovascular outcomes of OSA treatment. Further research is needed to improve diagnostic specificity and reduce misclassification risks.
Practical Considerations
- The record identifies an adult-use device; pediatric use should not be assumed without separate labeling.
- The monitor may require compatible patient sensors, leads, cables, and recording or display equipment.
- This device category monitors breathing patterns and does not by itself replace a complete sleep evaluation or clinical interpretation.
- The available record does not establish MRI safety; MRI compatibility should be confirmed in the original manufacturer labeling before use near an MRI system.
- Use should follow the cleared instructions, including sensor placement, electrical safety precautions, cleaning, and maintenance requirements.
Frequently Asked Questions
What are the clinical indications for adult apnea monitor 20?
The device is indicated for monitoring and diagnosing obstructive sleep apnea in adults, particularly in clinical settings.
What outcomes have been reported in clinical studies?
Studies report a global OSA prevalence of 22.6% and highlight the risk of misdiagnosis based on single-night assessments.
What complications have been reported?
Safety data indicate potential misclassification of OSA severity due to night-to-night variability, but no device-specific adverse events were noted.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.