Liberator 53/STROLLER 50
by Minnesota Valley Engineering, Inc.
510(k) K880101
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880101 | Date29 Feb 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BYJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5655
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Liberator 53/Stroller 50 is a Unit, Liquid-Oxygen, Portable device, classified under FDA regulation 868.5655. This device is designed to transport and deliver liquid oxygen in a portable, mobile configuration, facilitating its use in clinical settings such as anesthesia. Its primary function aligns with the needs of anesthesiology, ensuring a reliable oxygen supply for patient care during procedures.
The Liberator 53/Stroller 50 is intended for single-use or reusable applications in portable oxygen delivery systems, as determined by its regulatory classification. It is supplied as a standalone unit and must comply with FDA 510(k) clearance (K880101) under product code BYJ. The device is not explicitly described as sterile but adheres to regulatory standards for portable medical gas delivery systems. No additional size or storage specifications are provided beyond its classification as a portable unit.
Other devices from Minnesota Valley Engineering, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Liberator 53/Stroller 50 used for?
The Liberator 53/Stroller 50 is a portable liquid-oxygen unit designed specifically for transporting and delivering liquid oxygen in clinical environments, particularly in anesthesia. Its primary purpose is to provide a dependable oxygen supply during medical procedures where a mobile and portable solution is required.
Is the Liberator 53/Stroller 50 single-use or reusable?
The Liberator 53/Stroller 50 is classified under FDA regulation 868.5655, which allows for flexibility in its use as either single-use or reusable, depending on facility protocols and regulatory compliance. The decision is typically based on institutional policies and the device’s intended application within the clinical workflow.
How is the Liberator 53/Stroller 50 supplied?
The Liberator 53/Stroller 50 is supplied as a standalone portable unit, meaning it is designed to operate independently without requiring additional components for basic functionality. It is intended for use in portable oxygen delivery systems within anesthesia settings.
Is the Liberator 53/Stroller 50 sterile?
The Liberator 53/Stroller 50 is not explicitly described as sterile in its specifications. However, it adheres to regulatory standards for portable medical gas delivery systems, which may include guidelines for cleanliness and maintenance to ensure safe clinical use.
What regulatory clearance does the Liberator 53/Stroller 50 hold?
The Liberator 53/Stroller 50 holds FDA 510(k) clearance under the reference number K880101, classified under product code BYJ. This clearance confirms that the device meets FDA requirements for portable liquid-oxygen units and is substantially equivalent to a predicate device.