Model 379 Wxygen Concentrator
510(k) K801523
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801523 | Date14 Jul 1980 | 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- Withdrawn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
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Model 379 Wxygen Concentrator is a portable oxygen generator designed to deliver concentrated oxygen for medical use. It operates by extracting oxygen from ambient air and delivering it at a controlled flow rate, typically used in anesthesia and respiratory support applications. This device is classified as a portable oxygen generator and falls under the regulatory category for medical specialty anesthesia equipment.
The Model 379 Wxygen Concentrator is supplied as a reusable medical device and is intended for use in clinical settings where portable oxygen delivery is required. It is regulated under FDA 510(k) clearance (K801523) and falls under the classification of Class II devices (CAW). The device is not specified as MRI-safe or sterile, and its operational specifications, such as flow rates or pressure settings, are not detailed in the provided data. Storage and maintenance instructions are not included in the regulatory submission.
Other devices from Stanley Aviation Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Model 379 Wxygen Concentrator used for?
The Model 379 Wxygen Concentrator is designed to deliver concentrated oxygen for medical applications, primarily in anesthesia and respiratory support. It extracts oxygen from ambient air and delivers it at a controlled flow rate, making it suitable for clinical settings where portable oxygen delivery is required.
Is the Model 379 Wxygen Concentrator reusable or single-use?
The Model 379 Wxygen Concentrator is supplied as a reusable medical device. This means it is intended for repeated use in clinical environments after proper cleaning, maintenance, and sterilization procedures (if applicable). Reusability helps reduce waste and costs in healthcare settings.
What regulatory approval does the Model 379 Wxygen Concentrator hold?
The Model 379 Wxygen Concentrator holds FDA 510(k) clearance under the reference number K801523. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness in its intended use.
Is the Model 379 Wxygen Concentrator sterile?
The provided data does not specify that the Model 379 Wxygen Concentrator is sterile. Sterility is not mentioned in the regulatory submission, so users should follow manufacturer guidelines for cleaning and maintenance to ensure safe reuse in clinical settings.
What are the key specifications or features of the Model 379 Wxygen Concentrator?
The Model 379 Wxygen Concentrator is classified as a portable oxygen generator under the regulatory category for medical specialty anesthesia equipment. It is designed to operate by extracting oxygen from ambient air and delivering it at a controlled flow rate. While specific operational details like flow rates or pressure settings are not provided, it is intended for use in anesthesia and respiratory support applications.