510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NVPClass II

Holding Chambers, Direct Patient Interface

21 CFR 868.5630 / Anesthesiology
FDA source (opens on fda.gov)

NVP is the FDA product code for Holding Chambers, Direct Patient Interface, a class II device type, regulated under 21 CFR 868.5630. FDA's definition for this code reads: "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...". As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NVP
Device name
Holding Chambers, Direct Patient Interface
FDA 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
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
3

Clearances, product code NVP

By decision year
16 clearances under product code NVP with a decision year between 2005 and 2025, 2011 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NVP by decision year
YearClearances
20051
20071
20081
20114
20121
20132
20141
20161
20171
20191
20221
20251

Applicants with the most clearances

Product code NVP
Applicants holding the most 510(k) clearances under product code NVP
ApplicantClearances
Trudell Medical Intl.4
Medical Developments International2
Thayer Medical Corportation2
Trudell Medical International2
Activaero America, Inc.1
Aga Plastic Ind. Com. Ltda.1
Fsc Laboratories, Inc.1
Inspirx, Inc.1
Koo (Shanghai) Industries Co., Ltd1
Respironics New Jersey, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order