Holding Chambers, Direct Patient Interface
The Direct Patient Interface Holding Chamber is a device used with nebulizers and metered dose inhalers, comprising a reservoir into which aerosol medication is dispensed and a valved mouthpiece through which the patient inhales the medication. Unlike open spacers, holding chambers use a one-way valve to allow inhalation of suspended medication after actuation. It is an FDA Class 2 device regulated under 21 CFR 868.5630 in the Anesthesiology specialty, with product code NVP, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NVP
- Device Class
- FDA class 2
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Jan 15, 2025 | Substantially Equivalent | Trudell Medical International |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Apr 01, 2022 | Substantially Equivalent | Thayer Medical Corporation |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | Jan 11, 2019 | Substantially Equivalent | Trudell Medical International |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | May 19, 2017 | Substantially Equivalent | Thayer Medical Corporation |
| K143615 | Antistatic Compact Space Chamber | Jan 26, 2016 | Substantially Equivalent | Medical Developments International Limited |
| K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER | Oct 03, 2014 | Substantially Equivalent | Fsc Laboratories, Inc. |
| K122252 | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS | Nov 13, 2013 | Substantially Equivalent | Medical Developments International |
| K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | Jun 05, 2013 | Substantially Equivalent | Inspirx, Inc. |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | Jul 11, 2012 | Substantially Equivalent | Trudell Medical Intl. |
| K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | Aug 09, 2011 | Substantially Equivalent | Respironics New Jersey, Inc. |
| K101348 | AGACHAMBER SPACER | Apr 29, 2011 | Substantially Equivalent | Aga Plastic Ind. Com. Ltda. |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Apr 18, 2011 | Substantially Equivalent | Trudell Medical Intl. |
| K101136 | FISIO CHAMBER SPACE | Jan 28, 2011 | Substantially Equivalent | Koo (Shanghai) Industries Co., Ltd. |
| K080100 | WATCHHALER | Jun 30, 2008 | Substantially Equivalent | Activaero America, Inc. |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | Apr 11, 2007 | Substantially Equivalent | Trudell Medical Intl. |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Sep 21, 2005 | Substantially Equivalent | Trudell Medical Intl. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.