CAF — Nebulizer (Direct Patient Interface) Class II
FDA Device Classification
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 |
|---|
| 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 |
| K220869 | vapotherm | Vapotherm Aerosol Adapter AAA-2 | October 28, 2022 |