FDA Product Code
FDA Product Code CAF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5630
510(k) Clearances — 509 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | 2026-09-18 | Traditional | PDF ↗ |
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026-06-02 | Traditional | PDF ↗ |
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 | Traditional | PDF ↗ |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 | Traditional | PDF ↗ |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | 2025-07-02 | Traditional | PDF ↗ |
| K250022 | HeroTracker Sense | Voluntis | 2025-06-30 | Traditional | PDF ↗ |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | 2025-04-29 | Traditional | PDF ↗ |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | 2024-06-18 | Special | PDF ↗ |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024-04-10 | Traditional | PDF ↗ |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024-01-04 | Traditional | PDF ↗ |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 | Traditional | PDF ↗ |
| K230602 | Hudson RCI® TurboMist Nebulizer System | Medline Industries, LP | 2023-10-31 | Traditional | PDF ↗ |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023-08-30 | Traditional | PDF ↗ |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | 2023-08-24 | Traditional | PDF ↗ |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Medline Industries, Inc. | 2023-06-27 | Traditional | PDF ↗ |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | Medline Industires, Inc. | 2023-06-23 | Traditional | PDF ↗ |
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023-02-08 | Traditional | PDF ↗ |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | 2022-10-28 | Traditional | PDF ↗ |
| K221994 | Hailie Sensor NF0107 & NF0108 | Adherium (Nz), Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | 2022-07-15 | Traditional | PDF ↗ |
| K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 | Traditional | PDF ↗ |
| K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | 2021-12-10 | Traditional | PDF ↗ |
| K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | 2021-12-03 | Traditional | PDF ↗ |
| K203155 | BreatheSuite MDI V1 | Breathesuite, Inc. | 2021-09-17 | Traditional | PDF ↗ |
| K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021-08-18 | Traditional | PDF ↗ |
| K192971 | Nebulizer Kit | Excellentcare Medical (Huizhou) , Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K202171 | Pulmogine Vibrating Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2021-07-01 | Traditional | PDF ↗ |
| K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | 2021-06-14 | Traditional | PDF ↗ |
| K203400 | Corrugated tube with mouthpiece accessory | Trudell Medical International | 2021-06-14 | Traditional | PDF ↗ |
| K201167 | AireHealth NebulizerTM | Airehealth, Inc. | 2020-12-03 | Traditional | PDF ↗ |
| K182906 | Portable Mesh Nebulizer | Feellife Health, Inc. | 2020-09-27 | Traditional | PDF ↗ |
| K200063 | AeroEclipse* ONE BAN | Trudell Medical International | 2020-07-17 | Abbreviated | PDF ↗ |
| K192633 | GUS831 Compressor Nebulizer | Globalcare Medical Technology Co., Ltd. | 2020-05-01 | Traditional | PDF ↗ |
| K192724 | Propeller Sensor for Symbicort | Reciprocal Labs Corporation | 2020-03-26 | Traditional | PDF ↗ |
| K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020-01-23 | Traditional | PDF ↗ |
| K183586 | CapMedic | Cognita Labs, LLC | 2019-09-13 | Traditional | PDF ↗ |
| K182638 | Hailie Sensor | Adherium (Nz), Ltd. | 2019-06-19 | Traditional | PDF ↗ |
| K182573 | Hailie Sensor | Adherium (Nz), Ltd. | 2019-06-07 | Traditional | PDF ↗ |
| K181405 | Hailie Sensor | Adherium (Nz), Ltd. | 2018-12-10 | Traditional | PDF ↗ |
| K180871 | Portable Nebulizer | Microbase Technology Corporation | 2018-09-14 | Traditional | PDF ↗ |
| K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | 2018-08-31 | Traditional | PDF ↗ |
| K180770 | Propeller Sensor for Neohaler | Reciprocal Labs Corporation | 2018-08-01 | Traditional | PDF ↗ |
| K180407 | Smartinhaler | Adherium (Nz), Ltd. | 2018-07-25 | Traditional | PDF ↗ |
| K170886 | HOMED Mesh Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2018-06-21 | Traditional | PDF ↗ |
| K173825 | MC 300R* Nebulizer | Trudell Medical International | 2018-05-02 | Traditional | PDF ↗ |
| K173310 | SmartTouch | Adherium (Nz), Ltd. | 2018-03-26 | Traditional | PDF ↗ |
| K173367 | MC 300* Nebulizer | Trudell Medical International | 2018-02-28 | Traditional | PDF ↗ |
| K170916 | Portable Nebulizer | Microbase Technology Corporation | 2017-11-28 | Traditional | PDF ↗ |
| K170853 | InnoSpire Go | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 2017-11-02 | Traditional | PDF ↗ |
| K161586 | The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) | Shenzhen Homed Medical Device Co., Ltd. | 2017-09-06 | Traditional | PDF ↗ |
| K163485 | SmartTouch | Adherium (Nz), Ltd. | 2017-08-30 | Traditional | PDF ↗ |
| K153748 | AirLife Misty Finity Nebulizer | Care Fusion | 2017-05-17 | Traditional | PDF ↗ |
| K162041 | Airworks Nebulizer pe1200m | Convexity Scientific, LLC | 2017-05-02 | Traditional | PDF ↗ |
| K162785 | Velox Nebulizer System | Pari Respiratory Equipment, Inc. | 2017-04-14 | Traditional | PDF ↗ |
| K162753 | RTC 26-C Inline Aerosol Adapter | Instrumentation Industries, Inc. | 2017-02-28 | Traditional | PDF ↗ |
| K161454 | Propeller Sensor Model 2015-E | Reciprocal Labs Corporation | 2016-11-01 | Traditional | PDF ↗ |
| K153010 | Hudson RCI AquaPak Sterile Prefilled Nebulizers | Teleflexmedical, Inc. | 2016-07-26 | Traditional | PDF ↗ |
| K152882 | Propeller System | Reciprocal Labs | 2016-03-08 | Traditional | PDF ↗ |
| K152482 | Propeller Sensor Model 2014-R | Reciprocal Labs | 2016-03-04 | Traditional | PDF ↗ |
| K142541 | POCKET NEB | Microvaper Devices | 2016-01-22 | Abbreviated | PDF ↗ |
| K143719 | Aeroneb USB Contoller System | Aerogen Limited | 2015-07-10 | Traditional | PDF ↗ |
| K150591 | Besmed Reusable Jet Nebulizer | Besmed Health Business Corp | 2015-06-30 | Traditional | PDF ↗ |
| K143671 | Propeller Model 2014-D Sensor | Reciprocal Labs | 2015-06-19 | Traditional | PDF ↗ |
| K142516 | Propeller System | Reciprocal Labs Corporation | 2015-05-15 | Traditional | PDF ↗ |
| K142153 | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML | Teleflexmedical, Inc. | 2015-04-29 | Traditional | PDF ↗ |
| K142960 | Propeller System 2014-R | Reciprocal Labs | 2015-03-05 | Traditional | PDF ↗ |
| K142059 | FOX MOBILE | Vectura GmbH | 2015-01-09 | Traditional | PDF ↗ |
| K140237 | DISPOSABLE NEBULIZER SET | Suzhou Weikang Medical Apparatus Co., Ltd. | 2015-01-08 | Traditional | PDF ↗ |
| K141214 | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS | Teleflexmedical, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | Aerogen, Ltd. | 2014-10-17 | Traditional | PDF ↗ |
| K141140 | COMP A-I-R | Omron Healthcare, Inc. | 2014-09-30 | Traditional | PDF ↗ |
| K140919 | RESPICONNECT ADAPTER | Trudell Medical Int'L | 2014-08-15 | Traditional | PDF ↗ |
| K133105 | BREEZE NEBULIZER (NBR-10X) | Digio2 International Co., Ltd. | 2014-06-24 | Traditional | PDF ↗ |
| K140211 | ULTRASONIC MESH NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | 2014-05-30 | Special | PDF ↗ |
| K140638 | PROPELLER SYSTEM - MODEL 2 | Reciprocal Labs Corporation | 2014-05-02 | Traditional | PDF ↗ |
| K133951 | SMARTTOUCH | Nexus6, Ltd. | 2014-04-25 | Traditional | PDF ↗ |
| K132247 | ULTRASONIC MESH NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | 2014-01-08 | Traditional | PDF ↗ |
| K123030 | COMPRESSOR NEBULIZER MODEL MCN-S600XX | Dongguan Aidisy Machinery & Electronic Equipment C | 2013-12-19 | Traditional | PDF ↗ |
| K130379 | ROLLINS 7 OXYGEN MASK | Rollins Medical Solutions, Inc. | 2013-10-09 | Traditional | PDF ↗ |
| K123527 | AIRLIFE | Care Fusion | 2013-04-25 | Traditional | PDF ↗ |
| K121770 | HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER | Headstar Medical Products Co., Ltd. | 2013-04-17 | Traditional | PDF ↗ |
| K122060 | CLEVER TD-7001NEBULIZER | Taidoc Technology Corporation | 2013-03-21 | Traditional | PDF ↗ |
| K121520 | ULTRASONIC NEBULIZER (MESH TYPE) | K-Jump Health Co., Ltd. | 2013-03-15 | Abbreviated | PDF ↗ |
| K130091 | PULMOSAL | Pharmacaribe | 2013-03-13 | Special | PDF ↗ |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | Trudell Medical Intl. | 2013-03-11 | Traditional | PDF ↗ |
| K121969 | U-RIGHT COMPRESSOR NEBULIZER | Taidoc Technology Corporation | 2013-02-28 | Traditional | PDF ↗ |
| K122857 | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 | Pegasus Research Corp. | 2012-11-07 | Traditional | PDF ↗ |
| K121154 | ULTRASONIC NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | 2012-08-20 | Traditional | PDF ↗ |
| K111246 | SPIRALE DRUG DELIVERY SYSTEM | Armstrong Medical , Ltd. | 2012-08-10 | Traditional | PDF ↗ |
| K121609 | ASTHMAPOLIS SYSTEM | Reciprocal Labs Corporation | 2012-07-02 | Traditional | PDF ↗ |
| K112824 | QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER | Quality Life Technologies Co;Ltd | 2012-06-21 | Traditional | PDF ↗ |
| K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | Nephron Pharmaceuticals Corp. | 2012-06-19 | Traditional | PDF ↗ |
| K112859 | ERAPID NEBULIZER SYSTEM | Pari Respiratory Equipment, Inc. | 2012-05-30 | Traditional | PDF ↗ |
| K120939 | AERONEB PRO | Aerogen, Ltd. | 2012-04-26 | Special | PDF ↗ |
| K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML | Nephron Pharmaceuticals Corp. | 2012-04-20 | Traditional | PDF ↗ |
| K112041 | KOO SMALL VOLUME NEBULIZER (SVN) | Koo (Shanghai) Industries Co., Ltd. | 2011-12-22 | Traditional | PDF ↗ |
Product code CAF · Class II · Anesthesiology. Data: openFDA.