Atlas FDA

NVP

16 FDA 510(k) clearances · Product code

266 daysmedian time to decision
474 days90th percentile
16clearances measured

FDA profile

Official device name
Holding Chambers, Direct Patient Interface
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5630
Medical specialty
Anesthesiology
FDA 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
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RecordFirmDate
AeroChamber2go Anti-Static Valved Holding Chamber (K242667)Trudell Medical International2025-01-15
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber (K210558)Thayer Medical Corporation2022-04-01
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (K181649)Trudell Medical International2019-01-11
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (K160109)Thayer Medical Corporation2017-05-19
Antistatic Compact Space Chamber (K143615)Medical Developments International Limited2016-01-26
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER (K140062)Fsc Laboratories, Inc.2014-10-03
SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS (K122252)Medical Developments International2013-11-13
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER (K130598)Inspirx, Inc.2013-06-05
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (K112010)Trudell Medical Intl.2012-07-11
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER (K110293)Respironics New Jersey, Inc.2011-08-09
AGACHAMBER SPACER (K101348)Aga Plastic Ind. Com. Ltda.2011-04-29
RESPICHAMBER VALVED HOLDING CHAMBER (K110136)Trudell Medical Intl.2011-04-18
FISIO CHAMBER SPACE (K101136)Koo (Shanghai) Industries Co., Ltd.2011-01-28
WATCHHALER (K080100)Activaero America, Inc.2008-06-30
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR (K070674)Trudell Medical Intl.2007-04-11
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (K052332)Trudell Medical Intl.2005-09-21

Track NVP automatically

Every clearance here is in the API, with alerts when new ones post.