CAF — Nebulizer (Direct Patient Interface) Class II
FDA product code CAF covers "Nebulizer (Direct Patient Interface)", a Class II medical device regulated under 21 CFR 868.5630. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CAF
- Device Class
- Class II
- Regulation Number
- 868.5630
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260270 | findair sp. z o.o | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | June 2, 2026 |
| K251572 | pari respiratory equipment | eRapid with eTrack System | December 19, 2025 |
| K251659 | qingdao future medical technology co | Mesh Nebulizer (H6) | November 14, 2025 |
| K244035 | shenzhen jermei medical device technology co | Portable mesh nebulizer (JM821) | September 19, 2025 |
| K243468 | joytech healthcare co. | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul | July 2, 2025 |
| K250022 | voluntis | HeroTracker Sense | June 30, 2025 |
| K250583 | hcmed innovations co | AdheResp Smart Breath-actuated Mesh Nebulizer | June 20, 2025 |
| K242354 | enchant tek co. | AllNEB | April 29, 2025 |
| K233553 | thayer medical corporation | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | June 18, 2024 |
| K232507 | aerogen | Aerogen®Solo Nebulizer System | May 10, 2024 |
| K232523 | mankind pharma limited | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | April 10, 2024 |
| K231058 | medline industries | Hudson RCI® AddiPak® Unit Dose Vial | January 4, 2024 |
| K230379 | dongguan simzo electronic technology co | Portable (Ultrasonic) Nebulizer | November 27, 2023 |
| K230602 | medline industries | Hudson RCI® TurboMist Nebulizer System | October 31, 2023 |
| K223367 | ochsner clinic foundation | Ochsner Connected Inhaler Sensor | August 30, 2023 |
| K220145 | monaghan medical corporation | Monaghan medical filtered mouthpiece kit | August 24, 2023 |
| K223840 | pari respiratory equipment | eRapid Nebulizer System | August 11, 2023 |
| K223100 | medline industries | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | June 27, 2023 |
| K220955 | medline industires | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | June 23, 2023 |
| K222247 | adherium (nz) | Hailie Sensor NF0110 | February 8, 2023 |