Nebulization Kit & Adapter Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K780264 ↗

FDA Product Code

CAF

Device Class

Class II

Regulation

21 CFR Part 868.5630

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Chesebrough-Pond'S U.S.A. Co. →

• What is the Nebulization Kit & Adapter Kit used for?

  The Nebulization Kit & Adapter Kit is designed for nebulization procedures, converting liquid medication into a fine mist for inhalation therapy. It includes all necessary components for this medical application.

• Is the Nebulization Kit & Adapter Kit reusable or single-use?

  The Nebulization Kit & Adapter Kit is supplied as a single-use device and is not intended for reuse. This ensures sterility and proper functioning for each patient's treatment.

• What regulatory authorization does this device have?

  The Nebulization Kit & Adapter Kit is authorized under FDA 510K clearance with product code CAF. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.

• Is the Nebulization Kit & Adapter Kit MRI compatible?

  No, the Nebulization Kit & Adapter Kit is not MRI compatible. This should be considered when planning treatment environments where MRI imaging might be used.