Protege Liquid Oxygen System
by Healthdyne Technologies, Inc. 510(k)
Active
510(k) K971545
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971545 | Date25 Jul 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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 Protege Liquid Oxygen System is a portable liquid-oxygen delivery device designed for use in anesthesia. Classified as a Class II medical device under FDA product code BYJ, it provides a controlled supply of oxygen in gaseous form for patient respiration during surgical or critical care procedures.
This system is intended for single-use or reusable applications in operating rooms, recovery units, or emergency settings, depending on manufacturer guidelines. Supplied as a complete unit, it requires proper storage of liquid oxygen cylinders and adherence to regulatory standards for oxygen delivery systems. The device holds an FDA 510(k) clearance (K971545) and is subject to compliance with FDA Class II special controls, including performance testing and labeling requirements.
Other devices from Healthdyne Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Protege Liquid Oxygen System used for?
The Protege Liquid Oxygen System is a portable medical device designed specifically for anesthesia applications. It converts liquid oxygen into a controlled gaseous supply to support patient respiration during surgical procedures or critical care in operating rooms, recovery units, or emergency settings. The system ensures precise oxygen delivery, which is critical for maintaining safe anesthesia conditions.
Is the Protege Liquid Oxygen System single-use or reusable?
The Protege Liquid Oxygen System can be used either as a single-use device or as a reusable system, depending on the clinical setting and manufacturer guidelines. Single-use applications are common in controlled environments like operating rooms to minimize contamination risks, while reusable configurations may be employed in recovery units or emergency settings where repeated use is practical and properly maintained.
How is the Protege Liquid Oxygen System supplied?
The Protege Liquid Oxygen System is supplied as a complete unit, including all necessary components for liquid-oxygen conversion and gaseous delivery. It requires proper storage of liquid oxygen cylinders and adherence to regulatory standards for oxygen delivery systems. The system is designed to integrate seamlessly into anesthesia workflows, ensuring compatibility with existing clinical infrastructure.
What regulatory compliance does the Protege Liquid Oxygen System follow?
The Protege Liquid Oxygen System is classified as a Class II medical device under FDA product code BYJ and holds an FDA 510(k) clearance (K971545). It is subject to compliance with FDA Class II special controls, including performance testing and labeling requirements. The device is also designed to meet regulatory standards for oxygen delivery systems, ensuring safety and efficacy in anesthesia applications.
What are the key specifications for storage and handling?
The Protege Liquid Oxygen System requires proper storage of liquid oxygen cylinders to maintain safety and functionality. Liquid oxygen must be stored in designated, well-ventilated areas away from ignition sources, following manufacturer guidelines and regulatory standards. The system’s reusable components should be cleaned, inspected, and maintained according to established protocols to ensure reliable performance and prevent contamination.