Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC)
FDA 510(k) K112010 · Trudell Medical Intl.
510(k) numberK112010
Submission
- Device name
- Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC)
- Applicant
- Trudell Medical Intl.
London, CA - Received
- July 14, 2011
- Decision date
- July 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVP – Holding Chambers, Direct Patient Interface
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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
Other 510(k)s with product code NVP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding ChamberNVP · Traditional | Trudell Medical International | 01/15/2025SE |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberNVP · Traditional | Thayer Medical Corporation | 04/01/2022SE |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP · Traditional | Trudell Medical International | 01/11/2019SE |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberNVP · Traditional | Thayer Medical Corporation | 05/19/2017SE |
| K143615 | Antistatic Compact Space ChamberNVP · Traditional | Medical Developments International Limited | 01/26/2016SE |
| K140062 | FSC Anti-Static Valved Collapsible Holding ChamberNVP · Traditional | Fsc Laboratories, Inc. | 10/03/2014SE |
| K122252 | Space Chamber Plus Compact Space Chamber PlusNVP · Traditional | Medical Developments International | 11/13/2013SE |
| K130598 | Inspirachamber Anti-Static Valved Holding ChamberNVP · Traditional | Inspirx, Inc. | 06/05/2013SE |
| K110293 | Optichamber Diamond Valved Holding ChamberNVP · Traditional | Respironics New Jersey, Inc. | 08/09/2011SE |
| K101348 | Agachamber SpacerNVP · Traditional | Aga Plastic Ind. Com. Ltda. | 04/29/2011SE |
More from Aga Plastic Ind. Com. Ltda.
| 510(k) | Device | Decision |
|---|---|---|
| K131881 | Ombra Table Top CompressorBTI · Traditional | 10/24/2013SE |
| K123400 | Aerobika Positive Expiratory Pressure DeviceBWF · Traditional | 05/16/2013SE |
| K123614 | Solarys Ventilator Aerosol Delivery System (AS)CAF · Traditional | 03/11/2013SE |
| K110136 | Respichamber Valved Holding ChamberNVP · Traditional | 04/18/2011SE |
| K090065 | Aerochamber Mini Ventilation ChamberCAF · Traditional | 04/09/2009SE |
| K080926 | Aeroeclipse Durable Breath Actuated NebulizerCAF · Traditional | 08/12/2008SE |
| K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-Vu Inspiratory Flow…NVP · Special | 04/11/2007SE |
| K053605 | Aeroeclipse II Breath Actuated NebulizerCAF · Special | 02/27/2006SE |
| K052332 | Aerochamber Z-Stat Plus Valved Holding ChamberNVP · Special | 09/21/2005SE |
| K032972 | Aerochamber Max Valved Holding ChamberCAF · Special | 01/14/2004SE |
Questions and answers
When was Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC) cleared by the FDA?
Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC) (K112010) received a 510(k) decision of Substantially Equivalent on July 11, 2012, 363 days after the submission was received.
What is the product code of K112010?
The FDA product code is NVP – Holding Chambers, Direct Patient Interface, a Class II (moderate risk) device regulated under 21 CFR 868.5630.