DeviceClearance

Product code NVP— Anesthesiology

AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR

Classification name
Holding Chambers, Direct Patient Interface
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Total cleared
16
First cleared
Most recent

FDA classification definition

“Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles”

— U.S. Food and Drug Administration, device classification record for product code NVP under 21 CFR 868.5630, via openFDA

Market context for product code NVP

FDA has cleared 16 devices under product code NVP between 2005 and 2025, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NVP

Adverse events under product code NVP

product code NVP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NVP

Data sourced from openFDA. This site is unofficial and independent of the FDA.