Care ZY5BA Oxygen Concentrator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102245 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Care ZY5BA Oxygen Concentrator is a portable, electrically powered medical device classified as an oxygen generator. It functions by separating oxygen from ambient air using a compressor and molecular sieve technology, delivering high-purity supplemental oxygen through an outlet while filtering the remaining air in the room.
This device is intended for use in clinical settings, including anesthesia, and is supplied as a reusable, non-sterile medical instrument. It operates on AC power and is regulated under FDA 510(k) clearance (K102245) and the Medical Device Regulation (MDR). The Care ZY5BA adheres to Class II standards (FDA regulation number 868.5440) and is manufactured by Foshan Care Medical Technology Co., Ltd.
Frequently asked questions
Is the Care ZY5BA Oxygen Concentrator designed for single-use or can it be reused in clinical settings?
The Care ZY5BA Oxygen Concentrator is explicitly described as a reusable medical device. It is not intended for single-use and is meant to be used repeatedly in clinical settings, including anesthesia, as long as it is properly maintained and serviced according to manufacturer guidelines. Since it is non-sterile, it must be cleaned and disinfected between uses to ensure patient safety and device functionality.
What types of clinical environments is the Care ZY5BA Oxygen Concentrator approved for, and how does it differ from standard oxygen delivery systems?
The Care ZY5BA is intended for use in clinical settings, including anesthesia, as indicated by its advisory committee classification (Anesthesiology). Unlike traditional oxygen tanks or cylinders, this device is a portable oxygen generator that separates oxygen from ambient air using a compressor and molecular sieve technology. This allows it to provide a continuous supply of high-purity supplemental oxygen without the need for refilling, making it particularly useful in operating rooms or other clinical environments where a steady oxygen flow is required.
How is the Care ZY5BA Oxygen Concentrator powered, and does it require any special handling for storage or maintenance?
The Care ZY5BA Oxygen Concentrator operates on AC power, meaning it must be plugged into an electrical outlet to function. Since it is a reusable, non-sterile device, proper maintenance is critical—this includes regular cleaning, disinfection, and servicing to ensure its performance and longevity. While the device itself does not require special storage conditions beyond a clean, dry environment, the manufacturer’s instructions should be followed to avoid dust accumulation or exposure to extreme temperatures, which could affect its operation.
What regulatory pathways has the Care ZY5BA Oxygen Concentrator followed, and what does this mean for its use in healthcare facilities?
The Care ZY5BA has undergone FDA 510(k) clearance (K102245) and complies with the Medical Device Regulation (MDR). It is classified as a Class II device under FDA regulation number 868.5440, which means it has undergone rigorous review to ensure its safety and effectiveness for its intended use in clinical settings, including anesthesia. This regulatory clearance indicates that the device meets established standards for oxygen generators and can be legally marketed and used in healthcare facilities in the U.S. and other jurisdictions where MDR compliance is applicable.
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. Sources consulted: CARE ZY5BA OXYGEN CONCENTRATOR (K102245) — FDA 510 (k) | Innolitics, Care Zy5ba Oxygen Concentrator 510 (k) FDA Premarket Notification ..., fda.innolitics.com, FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. - fda.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K102245 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan Care Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K102245 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026