AeroEclipse* ONE BAN
FDA 510(k) K200063 · Trudell Medical International
510(k) numberK200063
Submission
- Device name
- AeroEclipse* ONE BAN
- Applicant
- Trudell Medical International
London, CA - Received
- January 13, 2020
- Decision date
- July 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
Other 510(k)s with product code CAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)CAF · Traditional | FindAir Sp. z o.o. | 06/02/2026SE |
| 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 |
|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding ChamberNVP · Traditional | 01/15/2025SE |
| K203400 | Corrugated tube with mouthpiece accessoryCAF · Traditional | 06/14/2021SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | 08/16/2019SE |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP · Traditional | 01/11/2019SE |
| K173918 | VersaPAP Positive Airway Pressure (PAP) DeviceBWF · Traditional | 08/17/2018SE |
| K173825 | MC 300R* NebulizerCAF · Traditional | 05/02/2018SE |
| K173367 | MC 300* NebulizerCAF · Traditional | 02/28/2018SE |
| K150173 | Aerobika OPEP Devive with ManometerBWF · Special | 10/15/2015SE |
Questions and answers
When was AeroEclipse* ONE BAN cleared by the FDA?
AeroEclipse* ONE BAN (K200063) received a 510(k) decision of Substantially Equivalent on July 17, 2020, 186 days after the submission was received.
What is the product code of K200063?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.