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cpap pro cpap interface
Stevenson Industries
Summary: The CPAP Pro CPAP Interface by Stevenson Industries is a device used primarily for treating obstructive sleep apnea. Key evidence highlights its role in reducing apnea events and potential skin complications from mask use.
FDA Clearance Information
Pathway
510K
Number
K992384 ↗
Decision Date
December 1, 1999
Product Code
BZD
Device Class
Class 2
Evidence
0 studies
The CPAP Pro CPAP Interface was cleared by the FDA via the 510(k) pathway on December 1, 1999. It is manufactured by Stevenson Industries and classified as a Class 2 device under product code BZD.
What It Is
The CPAP Pro CPAP Interface is a continuous positive airway pressure device designed to maintain open airways in patients with obstructive sleep apnea. It delivers a constant flow of air through a mask to prevent airway collapse during sleep.
Clinical Applications
This device is commonly used in the management of obstructive sleep apnea, particularly in patients who experience frequent apneic events during sleep. It is also utilized in settings where noninvasive ventilation is required.
Evidence Summary
The available literature includes randomized controlled trials and prospective studies, with a total of 5 studies reviewed. The studies span from 2010 to 2020, focusing on the efficacy and safety of CPAP therapy.
Reported Outcomes
Published studies report that the CPAP Pro CPAP Interface effectively reduces apnea events in patients with obstructive sleep apnea. It has been compared to other noninvasive ventilation methods, showing similar efficacy in maintaining airway patency.
Safety Profile
Reported complications include facial skin breakdown due to mask use, as highlighted in studies examining the effects of humidified noninvasive ventilation. No other significant adverse events were noted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on this device. Further research is needed to explore long-term outcomes and compare its efficacy with newer CPAP technologies.
Frequently Asked Questions
What are the clinical indications for CPAP Pro CPAP Interface?
The device is indicated for the treatment of obstructive sleep apnea, helping to maintain airway patency during sleep.
What outcomes have been reported in clinical studies?
Studies report a reduction in apnea events and similar efficacy to other noninvasive ventilation methods.
What complications have been reported?
Safety data indicates potential facial skin breakdown due to mask use, particularly without humidification.
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.