Aeroneb USB Contoller System
FDA 510(k) K143719 · Aerogen Limited
510(k) numberK143719
Submission
- Device name
- Aeroneb USB Contoller System
- Applicant
- Aerogen Limited
Galway, IE - Received
- December 29, 2014
- Decision date
- July 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
| K244035 | Portable mesh nebulizer (JM821)CAF · Traditional | Shenzhen Jermei Medical Device Technology Co.… | 09/19/2025SE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional | Joytech Healthcare Co. , Ltd. | 07/02/2025SE |
| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251615 | Aerogen Pro-X1 Controller SystemSFP · Traditional | 09/02/2025SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | 05/10/2024SE |
| K133360 | Aeroneb Solo; Aeroneb Solo AdapterCAF · Traditional | 10/17/2014SE |
| K120939 | Aeroneb ProCAF · Special | 04/26/2012SE |
| K103635 | Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085…CAF · Special | 05/13/2011SE |
| K032849 | Aeroneb Go Nebulizer, Model AG-AG2000CAF · Traditional | 11/21/2003SE |
| K021175 | Aeroneb Professional Nebulizer System, MODEL#AG-AP6000CAF · Traditional | 05/15/2002SE |
| K003022 | Aeroneb Portable NebulizerCAF · Traditional | 10/13/2000SE |
| K992831 | Aeroneb II, Model Apn 200CAF · Traditional | 08/25/2000SE |
Questions and answers
When was Aeroneb USB Contoller System cleared by the FDA?
Aeroneb USB Contoller System (K143719) received a 510(k) decision of Substantially Equivalent on July 10, 2015, 193 days after the submission was received.
What is the product code of K143719?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.