Nebulizer (Direct Patient Interface)
FDA product code CAF · 492 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5630
- Review panel
- AN
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-07-20 – 2026-09-18
CAF
2026-09-18
CAF
2026-06-02
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
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CAF
2025-12-19
eRapid with eTrack System
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CAF
2025-11-14
Mesh Nebulizer (H6)
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CAF
2025-09-19
Portable mesh nebulizer (JM821)
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CAF
2025-07-02
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
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CAF
2025-06-30
HeroTracker Sense
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CAF
2025-06-20
AdheResp Smart Breath-actuated Mesh Nebulizer
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CAF
2025-04-29
AllNEB
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CAF
2024-06-18
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
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CAF
2024-05-10
Aerogen®Solo Nebulizer System
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CAF
2024-04-10
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
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CAF
2024-01-04
Hudson RCI® AddiPak® Unit Dose Vial
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CAF
2023-11-27
Portable (Ultrasonic) Nebulizer
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CAF
2023-10-31
Hudson RCI® TurboMist™ Nebulizer System
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CAF
2023-08-30
Ochsner Connected Inhaler Sensor
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CAF
2023-08-24
Monaghan medical filtered mouthpiece kit
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CAF
2023-08-11
eRapid Nebulizer System
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CAF
2023-06-27
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
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CAF
2023-06-23
Hudson RCI Variable concentration Large Volume Nebulizer (1770)
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CAF
2023-02-08
Hailie Sensor NF0110
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CAF
2022-10-28
Vapotherm Aerosol Adapter AAA-2
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CAF
2022-10-04
Hailie Sensor NF0107 & NF0108
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CAF
2022-07-15
Hailie Sensor NF0106
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CAF
2022-03-25
Nebulizer
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CAF
2021-12-10
Airvo Nebulizer Adapter
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CAF
2021-12-03
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
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CAF
2021-09-17
BreatheSuite MDI V1
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CAF
2021-08-18
Hailie Sensor NF0109
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CAF
2021-07-08
Nebulizer Kit
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CAF
2021-07-01
Pulmogine Vibrating Mesh Nebulizer
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CAF
2021-06-14
Corrugated tube with mouthpiece accessory
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CAF
2021-06-14
Ultrasonic Mesh Nebulizer
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CAF
2020-12-03
AireHealth NebulizerTM
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CAF
2020-09-27
Portable Mesh Nebulizer
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CAF
2020-07-17
AeroEclipse* ONE BAN
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CAF
2020-05-01
GUS831 Compressor Nebulizer
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CAF
2020-03-26
Propeller Sensor for Symbicort
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CAF
2020-01-23
Proneb Max
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CAF
2019-09-13
CapMedic
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CAF
2019-06-19
Hailie Sensor
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CAF
2019-06-07
Hailie Sensor
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CAF
2018-12-10
Hailie Sensor
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CAF
2018-09-14
Portable Nebulizer
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CAF
2018-08-31
Intelligent Mesh Nebulizer
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CAF
2018-08-01
Propeller Sensor for Neohaler
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CAF
2018-07-25
Smartinhaler
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CAF
2018-06-21
HOMED Mesh Nebulizer
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CAF
2018-05-02
MC 300R* Nebulizer
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CAF
2018-03-26
SmartTouch
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CAF
2018-02-28
MC 300* Nebulizer
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CAF
2017-11-28
Portable Nebulizer
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CAF
2017-11-02
InnoSpire Go
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CAF
2017-09-06
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
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CAF
2017-08-30
SmartTouch
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CAF
2017-05-17
AirLife Misty Finity Nebulizer
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CAF
2017-05-02
Airworks Nebulizer pe1200m
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CAF
2017-04-14
Velox Nebulizer System
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CAF
2017-02-28
RTC 26-C Inline Aerosol Adapter
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CAF
2016-11-01
Propeller Sensor Model 2015-E
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CAF
2016-07-26
Hudson RCI AquaPak Sterile Prefilled Nebulizers
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CAF
2016-03-08
Propeller System
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CAF
2016-03-04
Propeller Sensor Model 2014-R
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CAF
2016-01-22
POCKET NEB
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CAF
2013-12-19
COMPRESSOR NEBULIZER MODEL MCN-S600XX
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CAF
2013-10-09
ROLLINS 7 OXYGEN MASK
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CAF
2013-04-25
AIRLIFE
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CAF
2013-04-17
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
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CAF
2013-03-21
CLEVER TD-7001NEBULIZER
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CAF
2013-03-15
ULTRASONIC NEBULIZER (MESH TYPE)
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CAF
2013-03-13
PULMOSAL
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CAF
2013-03-11
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
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CAF
2013-02-28
U-RIGHT COMPRESSOR NEBULIZER
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CAF
2012-11-07
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
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CAF
2012-08-20
ULTRASONIC NEBULIZER
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CAF
2012-08-10
SPIRALE DRUG DELIVERY SYSTEM
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CAF
2012-07-02
ASTHMAPOLIS SYSTEM
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CAF
2012-06-21
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
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CAF
2012-06-19
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
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CAF
2012-05-30
ERAPID NEBULIZER SYSTEM
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CAF
2012-04-26
AERONEB PRO
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CAF
2012-04-20
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
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CAF
2011-12-22
KOO SMALL VOLUME NEBULIZER (SVN)
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CAF
2011-11-23
QUIXIE NEBULIZER
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CAF
2011-10-25
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
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CAF
2011-09-29
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
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CAF
2011-09-02
COMP A-I-R
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CAF
2011-07-01
ATLANTEAN TRIGGER NEBULIZER
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CAF
2011-06-09
AEROVENT PLUS CHC
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CAF
2011-05-13
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
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CAF
2011-03-14
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
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CAF
2011-01-07
SMDIA-1000
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CAF
2010-12-10
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
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CAF
2010-11-10
NIVO NEBULIZER SYSTEM
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CAF
2010-08-17
PHARMACARIBE INHALED SALINE SOLUTIONS
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CAF
2010-07-22
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
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CAF
2010-07-02
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
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CAF
2010-06-29
LITETOUCH MASK
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CAF
2010-05-06
PARI SINUS
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CAF
2010-02-22
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
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