| FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) (K260270) | FindAir Sp. z o.o. | 2026-06-02 |
| eRapid with eTrack System (K251572) | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| Mesh Nebulizer (H6) (K251659) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| Portable mesh nebulizer (JM821) (K244035) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) (K243468) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| HeroTracker Sense (K250022) | Voluntis | 2025-06-30 |
| AdheResp Smart Breath-actuated Mesh Nebulizer (K250583) | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| AllNEB (K242354) | Enchant Tek Co. , Ltd. | 2025-04-29 |
| MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (K233553) | Thayer Medical Corporation | 2024-06-18 |
| Aerogen®Solo Nebulizer System (K232507) | Aerogen, Ltd. | 2024-05-10 |
| Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (K232523) | Mankind Pharma Limited | 2024-04-10 |
| Hudson RCI® AddiPak® Unit Dose Vial (K231058) | Medline Industries, LP | 2024-01-04 |
| Portable (Ultrasonic) Nebulizer (K230379) | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| Hudson RCI® TurboMist™ Nebulizer System (K230602) | Medline Industries, LP | 2023-10-31 |
| Ochsner Connected Inhaler Sensor (K223367) | Ochsner Clinic Foundation | 2023-08-30 |
| Monaghan medical filtered mouthpiece kit (K220145) | Monaghan Medical Corporation | 2023-08-24 |
| eRapid Nebulizer System (K223840) | Pari Respiratory Equipment, Inc. | 2023-08-11 |
| Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) (K223100) | Medline Industries, Inc. | 2023-06-27 |
| Hudson RCI Variable concentration Large Volume Nebulizer (1770) (K220955) | Medline Industires, Inc. | 2023-06-23 |
| Hailie Sensor NF0110 (K222247) | Adherium (Nz), Ltd. | 2023-02-08 |
| Vapotherm Aerosol Adapter AAA-2 (K220869) | Vapotherm, Inc. | 2022-10-28 |
| Hailie Sensor NF0107 & NF0108 (K221994) | Adherium (Nz), Ltd. | 2022-10-04 |
| Hailie Sensor NF0106 (K220622) | Adherium (Nz), Ltd. | 2022-07-15 |
| Nebulizer (K212395) | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 |
| Airvo Nebulizer Adapter (K211560) | Fisher & Paykel Healthcare Limited | 2021-12-10 |
| Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% (K210126) | The Ritedose Corporation | 2021-12-03 |
| BreatheSuite MDI V1 (K203155) | Breathesuite, Inc. | 2021-09-17 |
| Hailie Sensor NF0109 (K211233) | Adherium (Nz), Ltd. | 2021-08-18 |
| Nebulizer Kit (K192971) | Excellentcare Medical (Huizhou) , Ltd. | 2021-07-08 |
| Pulmogine Vibrating Mesh Nebulizer (K202171) | Hcmed Innovations Co., Ltd. | 2021-07-01 |
| Corrugated tube with mouthpiece accessory (K203400) | Trudell Medical International | 2021-06-14 |
| Ultrasonic Mesh Nebulizer (K201397) | Shenzhen Ivankaca Technology Co., Ltd. | 2021-06-14 |
| AireHealth NebulizerTM (K201167) | Airehealth, Inc. | 2020-12-03 |
| Portable Mesh Nebulizer (K182906) | Feellife Health, Inc. | 2020-09-27 |
| AeroEclipse* ONE BAN (K200063) | Trudell Medical International | 2020-07-17 |
| GUS831 Compressor Nebulizer (K192633) | Globalcare Medical Technology Co., Ltd. | 2020-05-01 |
| Propeller Sensor for Symbicort (K192724) | Reciprocal Labs Corporation | 2020-03-26 |
| Proneb Max (K191270) | Pari Respiratory Equipment, Inc. | 2020-01-23 |
| CapMedic (K183586) | Cognita Labs, LLC | 2019-09-13 |
| Hailie Sensor (K182638) | Adherium (Nz), Ltd. | 2019-06-19 |
| Hailie Sensor (K182573) | Adherium (Nz), Ltd. | 2019-06-07 |
| Hailie Sensor (K181405) | Adherium (Nz), Ltd. | 2018-12-10 |
| Portable Nebulizer (K180871) | Microbase Technology Corporation | 2018-09-14 |
| Intelligent Mesh Nebulizer (K171549) | Qingdao Future Medical Technology Co., Ltd. | 2018-08-31 |
| Propeller Sensor for Neohaler (K180770) | Reciprocal Labs Corporation | 2018-08-01 |
| Smartinhaler (K180407) | Adherium (Nz), Ltd. | 2018-07-25 |
| HOMED Mesh Nebulizer (K170886) | Shenzhen Homed Medical Device Co., Ltd. | 2018-06-21 |
| MC 300R* Nebulizer (K173825) | Trudell Medical International | 2018-05-02 |
| SmartTouch (K173310) | Adherium (Nz), Ltd. | 2018-03-26 |
| MC 300* Nebulizer (K173367) | Trudell Medical International | 2018-02-28 |
| Portable Nebulizer (K170916) | Microbase Technology Corporation | 2017-11-28 |
| InnoSpire Go (K170853) | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 2017-11-02 |
| The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) (K161586) | Shenzhen Homed Medical Device Co., Ltd. | 2017-09-06 |
| SmartTouch (K163485) | Adherium (Nz), Ltd. | 2017-08-30 |
| AirLife Misty Finity Nebulizer (K153748) | Care Fusion | 2017-05-17 |
| Airworks Nebulizer pe1200m (K162041) | Convexity Scientific, LLC | 2017-05-02 |
| Velox Nebulizer System (K162785) | Pari Respiratory Equipment, Inc. | 2017-04-14 |
| RTC 26-C Inline Aerosol Adapter (K162753) | Instrumentation Industries, Inc. | 2017-02-28 |
| Propeller Sensor Model 2015-E (K161454) | Reciprocal Labs Corporation | 2016-11-01 |
| Hudson RCI AquaPak Sterile Prefilled Nebulizers (K153010) | Teleflexmedical, Inc. | 2016-07-26 |
| Propeller System (K152882) | Reciprocal Labs | 2016-03-08 |
| Propeller Sensor Model 2014-R (K152482) | Reciprocal Labs | 2016-03-04 |
| POCKET NEB (K142541) | Microvaper Devices | 2016-01-22 |
| Aeroneb USB Contoller System (K143719) | Aerogen Limited | 2015-07-10 |
| Besmed Reusable Jet Nebulizer (K150591) | Besmed Health Business Corp | 2015-06-30 |
| Propeller Model 2014-D Sensor (K143671) | Reciprocal Labs | 2015-06-19 |
| Propeller System (K142516) | Reciprocal Labs Corporation | 2015-05-15 |
| HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML (K142153) | Teleflexmedical, Inc. | 2015-04-29 |
| Propeller System 2014-R (K142960) | Reciprocal Labs | 2015-03-05 |
| FOX MOBILE (K142059) | Vectura GmbH | 2015-01-09 |
| DISPOSABLE NEBULIZER SET (K140237) | Suzhou Weikang Medical Apparatus Co., Ltd. | 2015-01-08 |
| AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS (K141214) | Teleflexmedical, Inc. | 2014-12-18 |
| AERONEB SOLO; AERONEB SOLO ADAPTER (K133360) | Aerogen, Ltd. | 2014-10-17 |
| COMP A-I-R (K141140) | Omron Healthcare, Inc. | 2014-09-30 |
| RESPICONNECT ADAPTER (K140919) | Trudell Medical Int'L | 2014-08-15 |
| BREEZE NEBULIZER (NBR-10X) (K133105) | Digio2 International Co., Ltd. | 2014-06-24 |
| ULTRASONIC MESH NEBULIZER (K140211) | Foshan Gaunying Electronics Co., Ltd. | 2014-05-30 |
| PROPELLER SYSTEM - MODEL 2 (K140638) | Reciprocal Labs Corporation | 2014-05-02 |
| SMARTTOUCH (K133951) | Nexus6, Ltd. | 2014-04-25 |
| ULTRASONIC MESH NEBULIZER (K132247) | Foshan Gaunying Electronics Co., Ltd. | 2014-01-08 |
| COMPRESSOR NEBULIZER MODEL MCN-S600XX (K123030) | Dongguan Aidisy Machinery & Electronic Equipment C | 2013-12-19 |
| ROLLINS 7 OXYGEN MASK (K130379) | Rollins Medical Solutions, Inc. | 2013-10-09 |
| AIRLIFE (K123527) | Care Fusion | 2013-04-25 |
| HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER (K121770) | Headstar Medical Products Co., Ltd. | 2013-04-17 |
| CLEVER TD-7001NEBULIZER (K122060) | Taidoc Technology Corporation | 2013-03-21 |
| ULTRASONIC NEBULIZER (MESH TYPE) (K121520) | K-Jump Health Co., Ltd. | 2013-03-15 |
| PULMOSAL (K130091) | Pharmacaribe | 2013-03-13 |
| SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) (K123614) | Trudell Medical Intl. | 2013-03-11 |
| U-RIGHT COMPRESSOR NEBULIZER (K121969) | Taidoc Technology Corporation | 2013-02-28 |
| HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 (K122857) | Pegasus Research Corp. | 2012-11-07 |
| ULTRASONIC NEBULIZER (K121154) | Foshan Gaunying Electronics Co., Ltd. | 2012-08-20 |
| SPIRALE DRUG DELIVERY SYSTEM (K111246) | Armstrong Medical , Ltd. | 2012-08-10 |
| ASTHMAPOLIS SYSTEM (K121609) | Reciprocal Labs Corporation | 2012-07-02 |
| QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER (K112824) | Quality Life Technologies Co;Ltd | 2012-06-21 |
| SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML (K113033) | Nephron Pharmaceuticals Corp. | 2012-06-19 |
| ERAPID NEBULIZER SYSTEM (K112859) | Pari Respiratory Equipment, Inc. | 2012-05-30 |
| AERONEB PRO (K120939) | Aerogen, Ltd. | 2012-04-26 |
| SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML (K120051) | Nephron Pharmaceuticals Corp. | 2012-04-20 |
| KOO SMALL VOLUME NEBULIZER (SVN) (K112041) | Koo (Shanghai) Industries Co., Ltd. | 2011-12-22 |
| QUIXIE NEBULIZER (K112564) | Odyssey Medical Technologies | 2011-11-23 |