OptiChamber Advantage Anti-Static Valved Holding Chamber

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K072418 ↗

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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• What is the OptiChamber Advantage Anti-Static Valved Holding Chamber used for?

  It is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery, designed to leave larger non-respirable drug particles within the device while allowing smaller respirable particles to reach the lungs.

• Is the OptiChamber Advantage Anti-Static Valved Holding Chamber reusable or single-use?

  The device is supplied as a reusable holding chamber, as stated in the description, and is indicated for use in respiratory therapy settings, meaning it is intended for multiple uses after proper cleaning.

• Does the OptiChamber Advantage Anti-Static Valved Holding Chamber come in different sizes or models?

  The provided data does not specify any sizes, models, or reference numbers beyond the device name, so no variations in size or model are indicated in the available information.

• Is the OptiChamber Advantage Anti-Static Valved Holding Chamber sterile when supplied?

  No claims regarding sterility are present in the provided data, so the device is not indicated as sterile upon supply and should be cleaned according to manufacturer instructions before use.

• What regulatory pathway was used for the OptiChamber Advantage Anti-Static Valved Holding Chamber?

  The device received FDA 510(k) clearance under submission number K072418, as explicitly stated in the AUTHORIZATIONS and SPECIFICATIONS sections, confirming its regulatory route as a traditional 510(k) submission.