CAF
- Product code
- CAF
- Device name
- Nebulizer (Direct Patient Interface)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5630
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 14
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 508 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260270 | 2026-06-02 | FindAir Sp. z o.o. | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | |
| K251572 | 2025-12-19 | Pari Respiratory Equipment, Inc. | eRapid with eTrack System | |
| K251659 | 2025-11-14 | Qingdao Future Medical Technology Co.,… | Mesh Nebulizer (H6) | |
| K244035 | 2025-09-19 | Shenzhen Jermei Medical Device Technol… | Portable mesh nebulizer (JM821) | |
| K243468 | 2025-07-02 | Joytech Healthcare Co. , Ltd. | Compressor Nebulizer (NB-1100); Compressor Nebulizer… | |
| K250022 | 2025-06-30 | Voluntis | HeroTracker Sense | |
| K250583 | 2025-06-20 | Hcmed Innovations Co., Ltd. | AdheResp Smart Breath-actuated Mesh Nebulizer | |
| K242354 | 2025-04-29 | Enchant Tek Co. , Ltd. | AllNEB | |
| K233553 | 2024-06-18 | Thayer Medical Corporation | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A… | FDA |
| K232507 | 2024-05-10 | Aerogen, Ltd. | Aerogen®Solo Nebulizer System | FDA |
| K232523 | 2024-04-10 | Mankind Pharma Limited | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & … | FDA |
| K231058 | 2024-01-04 | Medline Industries, LP | Hudson RCI® AddiPak® Unit Dose Vial | |
| K230379 | 2023-11-27 | Dongguan Simzo Electronic Technology C… | Portable (Ultrasonic) Nebulizer | |
| K230602 | 2023-10-31 | Medline Industries, LP | Hudson RCI® TurboMist Nebulizer System |
Official FDA classification page: CAF
Classification and pathway per current FDA publications. Data from openFDA (CC0).