NVP — Holding Chambers, Direct Patient Interface Class II
FDA product code NVP covers "Holding Chambers, Direct Patient Interface", a Class II medical device regulated under 21 CFR 868.5630. Submissions are reviewed by the Anesthesiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NVP
- Device Class
- Class II
- Regulation Number
- 868.5630
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242667 | trudell medical international | AeroChamber2go Anti-Static Valved Holding Chamber | January 15, 2025 |
| K210558 | thayer medical corporation | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | April 1, 2022 |
| K181649 | trudell medical international | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | January 11, 2019 |
| K160109 | thayer medical corporation | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | May 19, 2017 |
| K143615 | medical developments international limited | Antistatic Compact Space Chamber | January 26, 2016 |
| K140062 | fsc laboratories | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER | October 3, 2014 |
| K122252 | medical developments international | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS | November 13, 2013 |
| K130598 | inspirx | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | June 5, 2013 |
| K112010 | trudell medical intl | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | July 11, 2012 |
| K110293 | respironics new jersey | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | August 9, 2011 |
| K101348 | aga plastic ind. com. ltda | AGACHAMBER SPACER | April 29, 2011 |
| K110136 | trudell medical intl | RESPICHAMBER VALVED HOLDING CHAMBER | April 18, 2011 |
| K101136 | koo (shanghai) industries co | FISIO CHAMBER SPACE | January 28, 2011 |
| K080100 | activaero america | WATCHHALER | June 30, 2008 |
| K070674 | trudell medical intl | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLO | April 11, 2007 |
| K052332 | trudell medical intl | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | September 21, 2005 |