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Oasis Humidifier

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964653

by Respironics, Inc.

Identifiers

510(k) Number
K964653 FDA 510(k)
FDA Product Code
BTT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5450 FDA 510(k)
Regulation Number
868.5450 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Oasis Humidifier is a respiratory gas humidifier designed for direct patient interface use. It is intended to add moisture to the patient circuit in CPAP and BiPAP systems, ensuring adequate humidification during respiratory therapy.

This device is supplied as a reusable accessory for Respironics CPAP and BiPAP systems, with no indication of sterility requirements in the provided data. It is classified under product code BTT as a Class II medical device under FDA regulation 868.5450. The humidifier was cleared by the FDA in 1997 following a 510(k) submission, with no third-party review involved.

Frequently asked questions

What is the Oasis Humidifier primarily used for in clinical settings?

The Oasis Humidifier is designed to add moisture to the patient circuit in CPAP (Continuous Positive Airway Pressure) and BiPAP (Bilevel Positive Airway Pressure) systems. Its purpose is to ensure adequate humidification during respiratory therapy, helping to maintain comfort and reduce potential irritation for patients receiving these treatments.

Is the Oasis Humidifier intended for single-use or reusable applications?

The Oasis Humidifier is supplied as a reusable accessory for Respironics CPAP and BiPAP systems. There is no indication in the provided data that it requires sterility, so it is intended for repeated use within a clinical setting, assuming proper cleaning and maintenance protocols are followed.

How was the Oasis Humidifier cleared by the FDA, and what does that mean for its regulatory status?

The Oasis Humidifier was cleared by the FDA in 1997 through a 510(k) submission, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance was granted under the Anesthesiology advisory committee and classified as a Class II medical device (product code BTT). No third-party review was involved in this process.

What types of systems is the Oasis Humidifier compatible with?

The Oasis Humidifier is specifically designed as an accessory for Respironics CPAP and BiPAP systems, ensuring compatibility with these respiratory therapy devices. It is not intended for use with other brands or systems unless explicitly stated by the manufacturer.

Are there any special storage requirements for the Oasis Humidifier?

The provided data does not specify detailed storage instructions for the Oasis Humidifier. However, since it is a reusable device, it should be stored in a clean, dry environment to prevent contamination and ensure proper functionality. Always follow manufacturer guidelines for maintenance and cleaning to extend its lifespan and ensure safe use.

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: OASIS HUMIDIFIER by RESPIRONICS, INC. | FDA 510 (k) Summary, K964653 FDA 510(k) - OASIS HUMIDIFIER | Respironics, Inc., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA 510(k) K964653 24 fields · synced Sep 18, 2026