NVP · Holding Chambers, Direct Patient Interface
Anesthesiology · 21 CFR 868.5630 · Class 2
Overview
| Product Code | NVP |
|---|---|
| Device Name | Holding Chambers, Direct Patient Interface |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International | Jan 15, 2025 | SESE |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | Apr 1, 2022 | SESE |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | Trudell Medical International | Jan 11, 2019 | SESE |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | May 19, 2017 | SESE |
| K143615 | Antistatic Compact Space Chamber | Medical Developments International Limited | Jan 26, 2016 | SESE |
| K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER | Fsc Laboratories, Inc. | Oct 3, 2014 | SESE |
| K122252 | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS | Medical Developments International | Nov 13, 2013 | SESE |
| K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | Inspirx, Inc. | Jun 5, 2013 | SESE |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | Trudell Medical Intl. | Jul 11, 2012 | SESE |
| K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | Respironics New Jersey, Inc. | Aug 9, 2011 | SESE |
| K101348 | AGACHAMBER SPACER | Aga Plastic Ind. Com. Ltda. | Apr 29, 2011 | SESE |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Trudell Medical Intl. | Apr 18, 2011 | SESE |
| K101136 | FISIO CHAMBER SPACE | Koo (Shanghai) Industries Co., Ltd. | Jan 28, 2011 | SESE |
| K080100 | WATCHHALER | Activaero America, Inc. | Jun 30, 2008 | SESE |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | Trudell Medical Intl. | Apr 11, 2007 | SESE |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Trudell Medical Intl. | Sep 21, 2005 | SESE |
Top Applicants
- Trudell Medical Intl. — 4 clearances
- Thayer Medical Corporation — 2 clearances
- Trudell Medical International — 2 clearances
- Activaero America, Inc. — 1 clearance
- Aga Plastic Ind. Com. Ltda. — 1 clearance
