EasyCare Online
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K123557 FDA 510(k)
- FDA Product Code
- MNS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyCare Online is a Continuous, Non-Life-Supporting Ventilator (Product Code: MNS), designed for use in anesthesia settings. It provides controlled respiratory support during surgical procedures, ensuring consistent ventilation while patients are under anesthesia. The device is classified under Class II with Special Controls and is intended for short-term, non-emergency respiratory assistance.
This ventilator is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K123557, K132371) for use in anesthesia environments. It operates within the regulatory framework of 21 CFR 868.5895, adhering to standards for ventilator safety and performance. The device is not MRI-compatible and requires proper maintenance and storage as per manufacturer guidelines to ensure reliability and sterility.
Frequently asked questions
What is the EasyCare Online ventilator designed for?
The EasyCare Online is a Continuous, Non-Life-Supporting Ventilator specifically designed for use in anesthesia settings. It provides controlled respiratory support during surgical procedures, ensuring consistent ventilation while patients remain under anesthesia. This makes it ideal for short-term, non-emergency respiratory assistance in operating rooms.
Is the EasyCare Online ventilator reusable or single-use?
The EasyCare Online ventilator is supplied as a reusable medical device. Like other reusable ventilators, it requires proper maintenance, cleaning, and sterilization between uses to ensure reliability, safety, and sterility. The manufacturer provides guidelines for maintenance and storage to support its long-term use in clinical environments.
What regulatory approvals does the EasyCare Online ventilator hold?
The EasyCare Online ventilator is cleared by the FDA under the 510(k) pathway (with clearance numbers K123557 and K132371) and is classified as a Class II device with Special Controls. It adheres to regulatory standards outlined in 21 CFR 868.5895, ensuring compliance with ventilator safety and performance requirements for anesthesia use.
Can the EasyCare Online ventilator be used in MRI environments?
No, the EasyCare Online ventilator is not MRI-compatible. If used in or near an MRI environment, there is a risk of interference or damage to the device, which could compromise patient safety or device functionality. Always follow manufacturer guidelines for proper placement and use.
What maintenance and storage requirements does the EasyCare Online ventilator have?
The EasyCare Online ventilator requires adherence to manufacturer-provided maintenance and storage guidelines to ensure reliability and sterility. Proper cleaning, calibration, and periodic inspections are essential for reusable devices to prevent contamination or malfunctions. The manufacturer’s instructions should be followed closely to maintain optimal performance and compliance with regulatory standards.
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: Welcome to EasyCare Online, K132371 FDA 510(k) - EASYCARE ONLINE | Resmed, Ltd., K093684 - EASYCARE ONLINE | FDA 510 (k) | Resmed, Ltd., EASYCARE ONLINE (K093684) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123557 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K123557 24 fields · synced Oct 1, 2026