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AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230915

by Vyaire Medical, Inc.

Identifiers

510(k) Number
K230915 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AirLife Open Et Oxygen Mask and the AirLife Open Et+ Oxygen Mask are oxygen delivery devices that also capture a capnography signal for respiratory monitoring. They provide flexible oxygen flow rates from 1 to 15 L/min, including a flush capability, and create a distributed flow that forms a soft oxygen curtain while allowing oral access for procedures.

Both masks are cleared by the U.S. FDA under 510(k) (K230915) as substantially equivalent to a predicate device, with a traditional clearance type and an anesthesiology advisory committee review. They are supplied by Vyaire Medical, Inc. and identified by product code CCK; the Et+ version includes a tethered female/reflective pigtail to support continuous EtCO₂ monitoring across the care continuum.

Frequently asked questions

What oxygen flow rates does the AirLife Open Et mask support?

The mask provides flexible oxygen flow from 1 to 15 L/min, including a flush capability. This range allows clinicians to titrate oxygen precisely for each patient’s needs while maintaining a distributed flow that forms a soft oxygen curtain.

How does the mask capture a capnography signal?

Both the Open Et and Open Et+ masks are designed with a built‑in sampling port that draws exhaled gas past a sensor, enabling continuous EtCO₂ monitoring without interrupting oxygen delivery. The Et+ version adds a tethered reflective pigtail to support uninterrupted capnography across the care continuum.

What distinguishes the Open Et+ version from the standard Open Et mask?

The Open Et+ includes a tethered female/reflective pigtail, which facilitates continuous EtCO₂ monitoring and easier integration with monitoring equipment. Functionally, both masks deliver the same oxygen flow rates, but the Et+ offers enhanced capnography connectivity.

How is the device supplied and what is its regulatory status?

Vyaire Medical, Inc. supplies the masks under product code CCK. They have received traditional 510(k) clearance (K230915) from the U.S. FDA, classified as substantially equivalent to a predicate device, with review by the anesthesiology advisory committee.

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: AirLife® Open ET and ET+ Mask | AirLife, AirLife™ Open | AirLife, AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (K230915 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vyaire Medical, Inc.

Sources (1)

  • FDA 510(k) K230915 24 fields · synced Oct 6, 2026