Spirit Portable Liquid-Oxygen Unit
FDA 510(k)Class II (US FDA 510(k))
by Caire Inc.
Identifiers
- 510(k) Number
- K080023 FDA 510(k)
- FDA Product Code
- BYJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5655 FDA 510(k)
- Regulation Number
- 868.5655 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spirit Portable Liquid-Oxygen Unit is a Class II medical device classified as a portable liquid-oxygen unit, designed to deliver medical-grade oxygen in a portable format. It is intended for use in clinical settings where continuous or intermittent oxygen therapy is required, such as in anesthesia, critical care, or patient transport scenarios.
This device is supplied as a reusable system, requiring proper maintenance and calibration to ensure safe and accurate oxygen delivery. It is regulated under FDA clearance (510K K080023) and adheres to regulatory standards outlined in 21 CFR 868.5655. The unit is intended for use in non-MRI environments and must be stored in accordance with manufacturer guidelines to preserve functionality and sterility of associated components.
Frequently asked questions
Is the Spirit Portable Liquid-Oxygen Unit designed for single-use or can it be reused in clinical settings?
The Spirit Portable Liquid-Oxygen Unit is designed as a reusable system, meaning it is intended for repeated use in clinical environments like anesthesia, critical care, or patient transport. However, proper maintenance and calibration are required to ensure safe and accurate oxygen delivery each time it is used. This distinction is important because reusable devices must be cleaned, inspected, and serviced according to manufacturer guidelines to maintain performance and safety standards.
What types of clinical settings is this device primarily intended for, and why?
This device is primarily intended for clinical settings requiring continuous or intermittent oxygen therapy, such as anesthesia, critical care, or patient transport scenarios. The design of the Spirit Portable Liquid-Oxygen Unit as a portable system makes it particularly suited for environments where mobility and reliable oxygen delivery are critical, such as during surgical procedures, emergency transport, or in intensive care units where patients may need oxygen support outside of fixed locations.
How should the Spirit Portable Liquid-Oxygen Unit be stored to maintain its functionality and safety?
The Spirit Portable Liquid-Oxygen Unit must be stored in accordance with the manufacturer’s guidelines to preserve its functionality and ensure the sterility of associated components. While the device itself is reusable, its components may require specific storage conditions to prevent contamination or damage, particularly if they come into contact with patients or medical environments. Always refer to the manufacturer’s instructions for precise storage recommendations, as improper storage could compromise performance or safety.
What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?
The Spirit Portable Liquid-Oxygen Unit received FDA clearance through a 510(k) submission (K080023), specifically classified as a Class II medical device under the regulatory category 21 CFR 868.5655. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. Clinically, this means the device has undergone FDA review to ensure it complies with safety and effectiveness guidelines for portable liquid-oxygen delivery in non-MRI environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080023 | Class II | Active |
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Manufacturer
- Manufacturer
- Caire Inc.
- FDA Applicant
- Caire, Inc.
Sources (1)
- FDA 510(k) K080023 24 fields · synced Sep 19, 2026