Panels › Anesthesiology › Product code NVP · Class 2
Holding Chambers, Direct Patient Interface
Regulation 868.5630
0510(k)s in 12 months (16 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NVP
| Company | 510(k)s | Recalls |
|---|---|---|
| Trudell Medical Intl. | 4 | 0 |
| Cardinal Health Inc. | 0 | 2 |
| Fsc Laboratories, Inc. | 1 | 1 |
| Medical Developments International | 2 | 0 |
| Thayer Medical Corporation | 2 | 0 |
| Trudell Medical International | 2 | 0 |
| Activaero America, Inc. | 1 | 0 |
| Aga Plastic Ind. Com. Ltda. | 1 | 0 |
| Inspirx, Inc. | 1 | 0 |
| Koo (Shanghai) Industries Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2025 | K242667 | AeroChamber2go Anti-Static Valved Holding Chamber Trudell Medical International, CA | NVP |
| Apr 1, 2022 | K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber Thayer Medical Corporation | NVP |
| Jan 11, 2019 | K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) Trudell Medical International, CA | NVP |
| May 19, 2017 | K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber Thayer Medical Corporation | NVP |
| Jan 26, 2016 | K143615 | Antistatic Compact Space Chamber Medical Developments International Limited, AU | NVP |
| Oct 3, 2014 | K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER Fsc Laboratories, Inc. | NVP |
| Nov 13, 2013 | K122252 | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS Medical Developments International, AU | NVP |
| Jun 5, 2013 | K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER Inspirx, Inc. | NVP |
| Jul 11, 2012 | K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) Trudell Medical Intl., CA | NVP |
| Aug 9, 2011 | K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER Respironics New Jersey, Inc. | NVP |
| Apr 29, 2011 | K101348 | AGACHAMBER SPACER Aga Plastic Ind. Com. Ltda. | NVP |
| Apr 18, 2011 | K110136 | RESPICHAMBER VALVED HOLDING CHAMBER Trudell Medical Intl., CA | NVP |
| Jan 28, 2011 | K101136 | FISIO CHAMBER SPACE Koo (Shanghai) Industries Co., Ltd. | NVP |
| Jun 30, 2008 | K080100 | WATCHHALER Activaero America, Inc. | NVP |
| Apr 11, 2007 | K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR Trudell Medical Intl., CA | NVP |
| Sep 21, 2005 | K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER Trudell Medical Intl., CA | NVP |
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