Sleep Apnea Nasal CPAP System
by Puritan Bennett Corp. 510(k)
Active
510(k) K871693
Overview
The Sleep Apnea Nasal CPAP System is a device classified as an Attachment, Breathing, Positive End Expiratory Pressure, intended for the treatment of sleep apnea via nasal continuous positive airway pressure therapy. It is a Class II medical device that received FDA 510(k) clearance under K871693 on September 15, 1987, and is substantially equivalent to a legally marketed predicate device.
The system is manufactured by Puritan Bennett Corp. and is supplied as a reusable or single-use component depending on configuration, though specific sterility, MRI safety, size variants, storage conditions, and usage settings are not detailed in the provided data. It is regulated under FDA regulation number 868.5965 and falls under the Anesthesiology medical specialty and advisory committee classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871693 | Date15 Sep 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5965
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What is the primary medical purpose of the Sleep Apnea Nasal CPAP System, and how does it function?
The Sleep Apnea Nasal CPAP System is designed for the treatment of sleep apnea by delivering nasal continuous positive airway pressure (CPAP) therapy. It works by providing a steady stream of pressurized air through the nasal passages to keep the airway open during sleep, reducing interruptions in breathing caused by sleep apnea.
Is this device reusable or single-use, and are there any details about its sterility or cleaning requirements?
The Sleep Apnea Nasal CPAP System can be configured with reusable or single-use components, though the provided data does not specify which parts fall into each category or their sterility status. For reusable components, proper cleaning and maintenance protocols would be required to ensure patient safety and device functionality.
What regulatory pathway was followed for FDA clearance, and which medical specialty oversees its classification?
The device received FDA 510(k) clearance under K871693 on September 15, 1987, through a traditional review process and was deemed substantially equivalent to a predicate device. It is classified under the Anesthesiology medical specialty and falls under the purview of the Anesthesiology Advisory Committee (AN).
Are there multiple models or sizes available for this system, and how would a clinician determine the appropriate fit for a patient?
The provided data lists multiple FEI numbers (e.g., 3013557562, 3006061749), which may correspond to different models or configurations of the Sleep Apnea Nasal CPAP System. While specific sizing details (e.g., mask sizes, pressure settings) are not included, clinicians would typically select a model based on patient anatomy, comfort needs, and therapeutic requirements—often guided by manufacturer recommendations or clinical assessment.