Portable Oxygen Concentrator (Model: P2-S4 +3 more)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230702 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
- Models / Variants
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 Portable Oxygen Concentrator (Models: P2-S4, P2-S3, P2-K4, P2-K3) is a medical device classified as a Generator, Oxygen, Portable, designed to concentrate ambient air to deliver high-flow oxygen therapy. It is intended for patients requiring continuous or intermittent oxygen supplementation in ambulatory settings, providing a portable alternative to traditional oxygen cylinders or tanks.
These devices are supplied as reusable medical equipment, intended for use in clinical, homecare, or travel settings. They are not sterile and require proper maintenance as outlined in manufacturer instructions. The devices are classified as Class II under FDA regulations (868.5440) and have received FDA 510K clearance, MDD, and MDR authorisations. Each model variant may vary in specifications such as flow rate and battery capacity, as detailed in the manufacturer’s documentation.
Frequently asked questions
What types of settings can this Portable Oxygen Concentrator be used in, and how does its portability benefit patients?
This device is designed for use in ambulatory settings, providing a portable alternative to traditional oxygen cylinders or tanks. It is suitable for clinical environments, homecare, or travel, allowing patients requiring continuous or intermittent oxygen supplementation to maintain mobility and independence. The portability eliminates the need for bulky tanks, making it ideal for patients who need oxygen therapy outside of stationary environments.
Are these Portable Oxygen Concentrators single-use or reusable, and what maintenance is required?
These devices are reusable medical equipment, not intended for single-use. Since they are not sterile, they require regular maintenance as outlined in the manufacturer’s instructions to ensure proper function and hygiene. Maintenance includes cleaning, servicing, and battery care, which are critical for reliable performance and patient safety.
What regulatory pathways have these models undergone, and how does that affect their use?
The Portable Oxygen Concentrator (Models P2-S4, P2-S3, P2-K4, P2-K3) has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. This means the device has been evaluated for safety and performance according to applicable regulatory standards, ensuring compliance for use in markets requiring these certifications. The FDA classification under 868.5440 (Generator, Oxygen, Portable) confirms its intended use for concentrating ambient air to deliver high-flow oxygen therapy.
How do the different models (P2-S4, P2-S3, P2-K4, P2-K3) vary, and what factors should I consider when selecting one?
While the exact specifications (such as flow rate or battery capacity) are detailed in the manufacturer’s documentation, the models likely differ in performance characteristics tailored for specific patient needs. For example, some may prioritize longer battery life for travel, while others may offer higher flow rates for clinical use. When selecting a model, consider factors like patient oxygen requirements, usage environment (home vs. travel), and battery endurance to ensure compatibility with the intended application.
How should these devices be stored to maintain their functionality and safety?
Since these are reusable and non-sterile devices, storage should follow the manufacturer’s guidelines to prevent damage or contamination. Typically, this includes keeping the unit in a dry, clean environment away from direct sunlight or extreme temperatures. Batteries should be stored properly to avoid degradation, and any accessories (like cannulas or tubing) should be stored separately to maintain hygiene. Always refer to the manufacturer’s instructions for specific storage recommendations.
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 (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230702 | Class II | Active |
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Manufacturer
- FDA Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd.
Sources (2)
- FDA 510(k) K230702 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026