NVP — Holding Chambers, Direct Patient Interface Class II
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 |