Portable Oxygen Concentrator P2-TOC
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242718 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 Portable Oxygen Concentrator P2-TOC is a medical device classified as a Generator, Oxygen, Portable, designed to concentrate ambient air to deliver high-flow oxygen therapy. It operates by filtering and compressing atmospheric air to produce oxygen-enriched gas, suitable for patients requiring supplemental oxygen in ambulatory or home settings. The device is intended for continuous or intermittent use, providing a reliable oxygen supply without the need for liquid or compressed gas cylinders.
This device is supplied as a reusable medical instrument, intended for use in clinical and homecare environments. It is not sterile and requires cleaning and maintenance as specified by the manufacturer. The P2-TOC is FDA-cleared under the 510(k) Traditional pathway and complies with regulatory standards for Class II devices (regulation number 868.5440). No MRI safety information is provided, and the device is available in a 3-litre configuration as referenced in promotional materials. Storage and handling follow standard medical device protocols to ensure operational integrity.
Frequently asked questions
What is the P2-TOC Portable Oxygen Concentrator used for?
The P2-TOC Portable Oxygen Concentrator is designed to concentrate ambient air and deliver oxygen-enriched gas for supplemental oxygen therapy. It is intended for patients who require continuous or intermittent oxygen support in ambulatory (mobile) or home settings, eliminating the need for liquid or compressed gas cylinders.
Is the P2-TOC Portable Oxygen Concentrator single-use or reusable?
The P2-TOC is a reusable medical device, intended for use in both clinical and homecare environments. Since it is not sterile, it requires regular cleaning and maintenance as outlined by the manufacturer to ensure proper function and hygiene.
What size configuration is available for the P2-TOC?
The P2-TOC is available in a 3-litre configuration, as referenced in promotional materials. This size refers to the device’s internal oxygen storage or flow capacity, which supports high-flow oxygen therapy for extended periods.
How should the P2-TOC Portable Oxygen Concentrator be stored?
The P2-TOC should be stored following standard medical device protocols to maintain operational integrity. This includes keeping it in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture. Avoid storing it in areas with high humidity or where it may be exposed to dust or contaminants, as these factors can affect performance and longevity.
Does the P2-TOC require any special handling or maintenance?
Yes, the P2-TOC is not sterile and must be cleaned and maintained according to the manufacturer’s instructions. Regular maintenance ensures reliable operation, prevents malfunctions, and extends the device’s lifespan. Follow the provided guidelines for filter replacement, part inspections, and disinfection procedures to maintain optimal performance.
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: Portable oxygen concentrator Kingon P2, Kingon POC / About Kingon_Portable oxygen concentrator| POC | 精安医疗 | 便携 ..., Kingon P2-TOC Transportable Portable Oxygen Concentrator P2TOC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242718 | Class II | Active |
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Manufacturer
- FDA Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd.
Sources (1)
- FDA 510(k) K242718 24 fields · synced Oct 5, 2026