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Panels › Anesthesiology › Product code CAF · Class 2

Nebulizer (Direct Patient Interface)

Regulation 868.5630

4510(k)s in 12 months (509 all time)
0recalls in 12 months (36 all time)
25recalls that name a 510(k)
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Top companies in CAF

Company510(k)sRecalls
Airlife, Inc.160
Aerogen Limited94
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company013
Vortran Medical Technology 1, Inc.120
Salter Labs92
Thayer Medical Corp.92
Adherium (Nz), Ltd.100
Reciprocal Labs100
Omron Healthcare, Inc.71
Pari Innovative Manufacturers, Inc.80
Decided510(k)Device and applicantCode
Sep 18, 2026K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
Shenzhen Mericonn Technology Co., Ltd., CN
CAF
Jun 2, 2026K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
FindAir Sp. z o.o., PL
CAF
Dec 19, 2025K251572eRapid with eTrack System
Pari Respiratory Equipment, Inc.
CAF
Nov 14, 2025K251659Mesh Nebulizer (H6)
Qingdao Future Medical Technology Co., Ltd., CN
CAF
Sep 19, 2025K244035Portable mesh nebulizer (JM821)
Shenzhen Jermei Medical Device Technology Co., Ltd., CN
CAF
Jul 2, 2025K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB
Joytech Healthcare Co. , Ltd., CN
CAF
Jun 30, 2025K250022HeroTracker Sense
Voluntis, FR
CAF
Jun 20, 2025K250583AdheResp Smart Breath-actuated Mesh Nebulizer
Hcmed Innovations Co., Ltd., TW
CAF
Apr 29, 2025K242354AllNEB
Enchant Tek Co. , Ltd., TW
CAF
Jun 18, 2024K233553MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
Thayer Medical Corporation
CAF
May 10, 2024K232507Aerogen®Solo Nebulizer System
Aerogen, Ltd., IE
CAF
Apr 10, 2024K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
Mankind Pharma Limited, IN
CAF
Jan 4, 2024K231058Hudson RCI® AddiPak® Unit Dose Vial
Medline Industries, LP
CAF
Nov 27, 2023K230379Portable (Ultrasonic) Nebulizer
Dongguan Simzo Electronic Technology Co., Ltd., CN
CAF
Oct 31, 2023K230602Hudson RCI® TurboMist™ Nebulizer System
Medline Industries, LP
CAF
Aug 30, 2023K223367Ochsner Connected Inhaler Sensor
Ochsner Clinic Foundation
CAF
Aug 24, 2023K220145Monaghan medical filtered mouthpiece kit
Monaghan Medical Corporation
CAF
Aug 11, 2023K223840eRapid Nebulizer System
Pari Respiratory Equipment, Inc.
CAF
Jun 27, 2023K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
Medline Industries, Inc.
CAF
Jun 23, 2023K220955Hudson RCI Variable concentration Large Volume Nebulizer (1770)
Medline Industires, Inc.
CAF
Feb 8, 2023K222247Hailie Sensor NF0110
Adherium (Nz), Ltd., NZ
CAF
Oct 28, 2022K220869Vapotherm Aerosol Adapter AAA-2
Vapotherm, Inc.
CAF
Oct 4, 2022K221994Hailie Sensor NF0107 & NF0108
Adherium (Nz), Ltd., NZ
CAF
Jul 15, 2022K220622Hailie Sensor NF0106
Adherium (Nz), Ltd., NZ
CAF
Mar 25, 2022K212395Nebulizer
Shenzhen Homed Medical Device Co., Ltd., CN
CAF
Dec 10, 2021K211560Airvo Nebulizer Adapter
Fisher & Paykel Healthcare Limited, NZ
CAF
Dec 3, 2021K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
The Ritedose Corporation
CAF
Sep 17, 2021K203155BreatheSuite MDI V1
Breathesuite, Inc., CA
CAF
Aug 18, 2021K211233Hailie Sensor NF0109
Adherium (Nz), Ltd., NZ
CAF
Jul 8, 2021K192971Nebulizer Kit
Excellentcare Medical (Huizhou) , Ltd., CN
CAF
Jul 1, 2021K202171Pulmogine Vibrating Mesh Nebulizer
Hcmed Innovations Co., Ltd., TW
CAF
Jun 14, 2021K203400Corrugated tube with mouthpiece accessory
Trudell Medical International, CA
CAF
Jun 14, 2021K201397Ultrasonic Mesh Nebulizer
Shenzhen Ivankaca Technology Co., Ltd., CN
CAF
Dec 3, 2020K201167AireHealth NebulizerTM
Airehealth, Inc.
CAF
Sep 27, 2020K182906Portable Mesh Nebulizer
Feellife Health, Inc., CN
CAF
Jul 17, 2020K200063AeroEclipse* ONE BAN
Trudell Medical International, CA
CAF
May 1, 2020K192633GUS831 Compressor Nebulizer
Globalcare Medical Technology Co., Ltd., CN
CAF
Mar 26, 2020K192724Propeller Sensor for Symbicort
Reciprocal Labs Corporation
CAF
Jan 23, 2020K191270Proneb Max
Pari Respiratory Equipment, Inc.
CAF
Sep 13, 2019K183586CapMedic
Cognita Labs, LLC
CAF
Jun 19, 2019K182638Hailie Sensor
Adherium (Nz), Ltd., NZ
CAF
Jun 7, 2019K182573Hailie Sensor
Adherium (Nz), Ltd., NZ
CAF
Dec 10, 2018K181405Hailie Sensor
Adherium (Nz), Ltd., NZ
CAF
Sep 14, 2018K180871Portable Nebulizer
Microbase Technology Corporation, TW
CAF
Aug 31, 2018K171549Intelligent Mesh Nebulizer
Qingdao Future Medical Technology Co., Ltd., CN
CAF
Aug 1, 2018K180770Propeller Sensor for Neohaler
Reciprocal Labs Corporation
CAF
Jul 25, 2018K180407Smartinhaler
Adherium (Nz), Ltd., NZ
CAF
Jun 21, 2018K170886HOMED Mesh Nebulizer
Shenzhen Homed Medical Device Co., Ltd., CN
CAF
May 2, 2018K173825MC 300R* Nebulizer
Trudell Medical International, CA
CAF
Mar 26, 2018K173310SmartTouch
Adherium (Nz), Ltd., NZ
CAF

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