Holding Chambers, Direct Patient Interface
Anesthesiology · 21 CFR 868.5630
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 MDR events
14 adverse event reports on file
- ANTISTATIC COMPACT SPACE CHAMBERFeb 19, 2026InjuryMedical Developments International3005977696-2026-00001
- OPTICHAMBER DIAMONDNov 5, 2024MalfunctionRespironics, Inc.2518422-2024-103258
- LEADJul 4, 2024InjurySt. Jude Medical, Inc.(crm-sylmar)2017865-2024-58558
- MOBILE TRANSMITTER PATIENT SMARTPHONEJun 27, 2024MalfunctionSt. Jude Medical, Inc.(crm-sylmar)2017865-2024-58034
- HOLDING CHAMBERS, DIRECT PATIENT INTERFACEAug 12, 2023MalfunctionBiotronikMW5133321
- AEROCHAMBER PLUSJun 30, 2023OtherUnkMW5119071
- AEROCHAMBER PLUS FLOW-VU BLUE PLASTIC MOUTHPIECEOct 3, 2022InjuryTrudell Medical Intl.MW5112406
- AEROCHAMBER PLUS WITH MASK- MEDIUMMar 16, 2022InjuryUnkMW5108225
- HOLDING CHAMBERS, DIRECT PATIENT INTERFACEJan 5, 2021InjuryMW5098695
- SPACE CHAMBER PLUSJun 5, 2018MalfunctionMedical Developments International Ltd3005977696-2018-00003
Event type breakdown
Recalls
3 recall events for this product code
- FSC Laboratories, IncTerminatedJun 15, 2016
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(p
Product had torn/loose seal around the mouthpiece.
Z-1995-2016 · View FDA record ↗ - Cardinal Health Inc.Open, ClassifiedUnknown
AEROCHAMBER PLS W/MASK LRG BLU
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1932-2021 · View FDA record ↗ - Cardinal Health Inc.Open, ClassifiedUnknown
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1941-2021 · View FDA record ↗
Registered firms
34 firms currently registered for this product code
Inovo Inc.
Lehigh Acres, FL, US
Monaghan Medical Corp.
Plattsburgh, NY, US
Sunset Healthcare Solutions, Inc.
CHICAGO, IL, US
Foremount Enterprise Co., Ltd.
Taichung City, TW
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Hudson Scientific Llc
Hudson, MI, US
Ceva Logistics Limited
Daventry Northamptonshire, GB
Philips Electronics Ltd
Mississauga Ontario, CA
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Medical Developments International
Scoresby Victoria, AU
Nolato Gw Tucson
Tucson, AZ, US
Trudell Medical International
LONDON Ontario, CA
Sunset Healthcare Solutions Central Warehouse
Elgin, IL, US
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Ceplast Medical Devices, Llc
Miami, FL, US
Thayer Medical Corportation
TUCSON, AZ, US
Sunset Healthcare Solutions Warehouse
Phoenix, AZ, US
Respironics Medical Products (shenzhen) Co., Ltd.
Shenzhen Guangdong, CN
Respironics, Inc.
Mount Pleasant, PA, US
Clement Clarke Intl., Ltd.
Mountain Ash Rhondda Cynon Taff, GB
Respironics Inc.
MURRYSVILLE, PA, US
Simple Diagnostics
Maspeth, NY, US
510(k) clearances
16 clearances for this product code
- Trudell Medical InternationalJan 15, 2025
K242667 · AeroChamber2go Anti-Static Valved Holding Chamber
- Thayer Medical CorporationApr 1, 2022
K210558 · LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
- Trudell Medical InternationalJan 11, 2019
K181649 · AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
- Thayer Medical CorporationMay 19, 2017
K160109 · Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
- Medical Developments International LimitedJan 26, 2016
K143615 · Antistatic Compact Space Chamber
- Fsc Laboratories, Inc.Oct 3, 2014
K140062 · FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
- Medical Developments InternationalNov 13, 2013
K122252 · SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
- Inspirx, Inc.Jun 5, 2013
K130598 · INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER