Product code CAF
- Device name
- Nebulizer (Direct Patient Interface)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5630
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| K250022 | HeroTracker Sense | Voluntis | 2025-06-30 |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | 2025-04-29 |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | 2024-06-18 |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024-04-10 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024-01-04 |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023-10-31 |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023-08-30 |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | 2023-08-24 |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023-08-11 |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Medline Industries, Inc. | 2023-06-27 |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | Medline Industires, Inc. | 2023-06-23 |
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023-02-08 |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | 2022-10-28 |
| K221994 | Hailie Sensor NF0107 & NF0108 | Adherium (Nz), Ltd. | 2022-10-04 |
| K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | 2022-07-15 |
| K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 |
| K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | 2021-12-10 |
| K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | 2021-12-03 |
| K203155 | BreatheSuite MDI V1 | Breathesuite, Inc. | 2021-09-17 |
| K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021-08-18 |
| K192971 | Nebulizer Kit | Excellentcare Medical (Huizhou) , Ltd. | 2021-07-08 |
| K202171 | Pulmogine Vibrating Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2021-07-01 |
| K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | 2021-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09420012463159 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2024-08-15 |
| 10190752114883 | AirLife™ | VYAIRE MEDICAL, INC. | 2021-04-02 |
| 10080196418329 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196731428 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196731411 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196731404 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196715565 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196715558 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196715534 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10080196418336 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-12-01 |
| 09421032180323 | Hailie Sensor - for use only with Diskus | ADHERIUM (NZ) LIMITED | 2020-11-19 |
| 10190752114920 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114852 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114869 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114876 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114890 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114906 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114913 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114845 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114838 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114821 | AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 10190752114814 | AirLife™ | VYAIRE MEDICAL, INC. | 2020-01-15 |
| 09421032180286 | Hailie Sensor - for use only with Bevespi Aerosphere | ADHERIUM (NZ) LIMITED | 2019-06-12 |
| 09421032180279 | Hailie Sensor - for use only with Symbicort MDI | ADHERIUM (NZ) LIMITED | 2018-05-22 |
| 09421032180163 | Hailie Sensor - for use only with ProAir HFA | ADHERIUM (NZ) LIMITED | 2018-05-22 |
| 09421032180101 | Hailie Sensor - for use only with Flovent HFA | ADHERIUM (NZ) LIMITED | 2018-05-22 |
| 09421032180095 | Hailie Sensor - for use only with Advair HFA | ADHERIUM (NZ) LIMITED | 2018-05-22 |
| 09421032180071 | Hailie Sensor - for use only with Ventolin HFA | ADHERIUM (NZ) LIMITED | 2018-05-22 |
| 09421032180170 | Hailie Sensor - for use only with Ventolin HFA | ADHERIUM (NZ) LIMITED | 2016-09-26 |
| 09421032180262 | Hailie Sensor - for use only with ProAir HFA | ADHERIUM (NZ) LIMITED | 2016-09-24 |