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 |
|---|---|---|---|
| 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 |
| K202171 | Pulmogine Vibrating Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2021-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840117308732 | My Resp-O2 Bear Compressor Nebulizer | Dynarex Corporation | 2022-05-11 |
| 00840117308718 | Resp-O2 Compact Compressor Nebulizer | Dynarex Corporation | 2022-05-11 |
| 00840117308695 | Resp-O2 Elite Compressor Nebulizer, Adult/Pediatric | Dynarex Corporation | 2022-05-11 |
| 00840117311831 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311817 | Resp-O2 Small Volume Nebulizer | Dynarex Corporation | 2021-04-22 |
| 00840117308657 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117308633 | Resp-O2 Small Volume Nebulizer 6cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117308619 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311954 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311930 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117308671 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311855 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311879 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311893 | Resp-O2 Small Volume Nebulizer 6 cc Cup | Dynarex Corporation | 2021-04-22 |
| 00840117311916 | Resp-O2 Small Volume Pacifier Nebulizer Kit | Dynarex Corporation | 2021-04-22 |
| 00840117308756 | Dynarex My Resp-O2 Doggy Compressor Nebulizer | Dynarex Corporation | 2021-01-19 |
| 00840117308770 | My Resp-O2 Piggy Compressor Nebulizer | Dynarex Corporation | 2021-01-19 |
| 00840117308794 | My Resp-O2 Penguin Compressor Nebulizer | Dynarex Corporation | 2021-01-19 |
| 00885304000822 | DeVilbiss | DEVILBISS HEALTHCARE LLC | 2020-04-03 |
| 00885304001508 | DeVilbiss | DEVILBISS HEALTHCARE LLC | 2020-04-03 |
| 00885304002482 | DeVilbiss | DEVILBISS HEALTHCARE LLC | 2020-02-07 |
| 00885304002505 | DeVilbiss | DEVILBISS HEALTHCARE LLC | 2020-02-07 |
| 10889483300824 | Ventlab | VENTLAB, LLC | 2016-10-01 |
| 10889483300817 | Ventlab | VENTLAB, LLC | 2016-10-01 |
| 10889483300800 | Ventlab | VENTLAB, LLC | 2016-10-01 |
| 10889483300794 | Ventlab | VENTLAB, LLC | 2016-09-30 |
| 10889483300787 | Ventlab | VENTLAB, LLC | 2016-09-30 |
| 10889483300756 | Ventlab | VENTLAB, LLC | 2016-09-29 |
| 10889483300749 | Ventlab | VENTLAB, LLC | 2016-09-29 |
| 10889483300732 | Ventlab | VENTLAB, LLC | 2016-09-29 |