CAF · Nebulizer (Direct Patient Interface)
Anesthesiology · 21 CFR 868.5630 · Class 2
Overview
| Product Code | CAF |
|---|---|
| Device Name | Nebulizer (Direct Patient Interface) |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 507)
Showing 20 most recent of 507 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | Dec 19, 2025 | SESE |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | Nov 14, 2025 | SESE |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | Sep 19, 2025 | SESE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | Jul 2, 2025 | SESE |
| K250022 | HeroTracker Sense | Voluntis | Jun 30, 2025 | SESE |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | Jun 20, 2025 | SESE |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | Apr 29, 2025 | SESE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | Jun 18, 2024 | SESE |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | May 10, 2024 | SESE |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | Apr 10, 2024 | SESE |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | Jan 4, 2024 | SESE |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | Nov 27, 2023 | SESE |
| K230602 | Hudson RCI® TurboMist Nebulizer System | Medline Industries, LP | Oct 31, 2023 | SESE |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | Aug 30, 2023 | SESE |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | Aug 24, 2023 | SESE |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | Aug 11, 2023 | SESE |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Medline Industries, Inc. | Jun 27, 2023 | SESE |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | Medline Industires, Inc. | Jun 23, 2023 | SESE |
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | Feb 8, 2023 | SESE |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | Oct 28, 2022 | SESE |
Top Applicants
- Airlife, Inc. — 16 clearances
- Vortran Medical Technology 1, Inc. — 12 clearances
- Adherium (Nz), Ltd. — 10 clearances
- Salter Labs — 9 clearances
- Pari Innovative Manufacturers, Inc. — 8 clearances
