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 |
|---|---|---|---|
| K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | 2026-09-18 |
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026-06-02 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00789091681588 | Nebulizer Kit | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530096137 | Nebulizer Kit | Sunset Healthcare Solutions, Inc. | 2025-05-21 |
| 00848530087531 | Nebulizer Accessories | Sunset Healthcare Solutions, Inc. | 2024-08-07 |
| 00848530087517 | Nebulizer Medicine Cup | Sunset Healthcare Solutions, Inc. | 2024-08-07 |
| 00848530087524 | Power and Accessories | Sunset Healthcare Solutions, Inc. | 2024-08-07 |
| 00848530094805 | Nebulizer Kit | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530093853 | Aerosol & Nebs | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530093884 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530089818 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530087500 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530095062 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530095079 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-07-30 |
| 00848530087722 | Nebulizer Accessories | Sunset Healthcare Solutions, Inc. | 2024-07-15 |
| 00848530090395 | Nebulizer Mask | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530090869 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530090876 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530092573 | Nebulizer Mask | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530090081 | Nebulizer | Sunset Healthcare Solutions, Inc. | 2024-06-24 |
| 00848530095086 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-06-20 |
| 00848530096144 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-06-20 |
| 00848530091828 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-06-08 |
| 00848530091835 | Nebulizer and Compressor | Sunset Healthcare Solutions, Inc. | 2024-06-08 |
| 00848530090401 | Nebulizer Mask | Sunset Healthcare Solutions, Inc. | 2024-06-07 |
| 00848530092566 | Nebulizer Mask | Sunset Healthcare Solutions, Inc. | 2024-06-07 |
| 00848530089146 | Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit | Sunset Healthcare Solutions, Inc. | 2019-01-11 |
| 00848530087326 | Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530062330 | Sunset Healthcare Solutions Reusable Nebulizer Kit | Sunset Healthcare Solutions, Inc. | 2016-09-24 |
| 00848530060800 | Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask | Sunset Healthcare Solutions, Inc. | 2016-09-24 |
| 00848530060794 | Sunset Healthcare Solutions Disposable Nebulizer Kit w/T Mouthpiece | Sunset Healthcare Solutions, Inc. | 2016-09-24 |
| 00848530060787 | Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask | Sunset Healthcare Solutions, Inc. | 2016-09-24 |