Backpack Medical Oxygen System
by Essex Cryogenics of Missouri, Inc.
510(k) K071581
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071581 | Date11 Jul 2007 | 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- Withdrawn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 Backpack Medical Oxygen System is a portable, liquid-oxygen storage and gaseous delivery unit designed for anesthesiology applications. It operates as a low-pressure system, converting stored liquid oxygen into gaseous form for patient use. The device is classified as a Class II medical device under FDA regulations, intended for controlled oxygen delivery in clinical settings.
This system supplies up to 1,720 liters of gaseous oxygen at a maximum flow rate of 15 liters per minute at 50 psig, regulated via an integrated flow control valve. Supplied as a reusable device, it is intended for single-patient use per session and requires proper storage to maintain liquid oxygen integrity. Authorized under FDA 510(k) clearance (K071581), it adheres to regulation 868.5655 for portable liquid-oxygen systems, ensuring compliance with medical gas delivery standards.
Other devices from Essex Cryogenics of Missouri, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Backpack Medical Oxygen System used for?
The Backpack Medical Oxygen System is designed specifically for anesthesiology applications. It converts stored liquid oxygen into gaseous form to provide controlled oxygen delivery during surgical procedures. The system ensures a reliable oxygen supply at a regulated flow rate, supporting patient safety during anesthesia.
How is the Backpack Medical Oxygen System supplied and intended for use?
This device is supplied as a reusable unit and is intended for single-patient use per session. It is not meant for repeated use across multiple patients without proper refilling and maintenance. The design ensures liquid oxygen integrity when stored correctly, allowing for consistent performance during clinical use.
What are the key specifications for oxygen delivery in this system?
The system delivers up to 1,720 liters of gaseous oxygen at a maximum flow rate of 15 liters per minute at 50 psig. The integrated flow control valve regulates output, ensuring precise oxygen administration for anesthesia. This low-pressure system is optimized for controlled delivery in clinical settings.
Is the Backpack Medical Oxygen System sterile, and how should it be stored?
The device itself is not sterile—it is a reusable medical system intended for clinical use after proper cleaning and maintenance. To preserve liquid oxygen integrity, storage must follow manufacturer guidelines, typically in a cool, stable environment away from direct sunlight or extreme temperatures. Improper storage could compromise oxygen purity or system functionality.
What regulatory approval does this device hold, and how does it comply with standards?
The Backpack Medical Oxygen System holds FDA 510(k) clearance (K071581) under regulation 868.5655, classifying it as a Class II medical device for portable liquid-oxygen systems. It adheres to standards for medical gas delivery in anesthesiology, ensuring safety and performance in controlled clinical environments.