Monaghan medical filtered mouthpiece kit
FDA 510(k) K220145 · Monaghan Medical Corporation
510(k) numberK220145
Submission
- Device name
- Monaghan medical filtered mouthpiece kit
- Applicant
- Monaghan Medical Corporation
Plattsburgh, NY, US - Received
- January 19, 2022
- Decision date
- August 24, 2023
- 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
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 |
|---|---|---|
| K123945 | Strive Dual Zone Peak Flow MeterBZH · Traditional | 04/17/2013SE |
| K110273 | Aerovent Plus CHCCAF · Traditional | 06/09/2011SE |
| K031514 | Modification to Trupeak Peak Flow MeterBZH · Special | 05/23/2003SE |
| K023097 | Truezone Peak Flow MeterBZH · Abbreviated | 03/07/2003SE |
| K012939 | Aerovent II CHC Collapsible Holding ChamberCAF · Special | 09/28/2001SE |
| K991212 | Modification to Truzone Peak Flow MeterBZH · Abbreviated | 07/01/1999SE |
| K964130 | Aerogear Asthma Action KitBZH · Traditional | 01/10/1997SE |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | 11/06/1996SE |
| K963095 | Trupeak Peak Flow MeterBZH · Traditional | 11/04/1996SE |
| K955234 | Trupeak Peak Flow MeterBZH · Traditional | 03/18/1996SE |
Questions and answers
When was Monaghan medical filtered mouthpiece kit cleared by the FDA?
Monaghan medical filtered mouthpiece kit (K220145) received a 510(k) decision of Substantially Equivalent on August 24, 2023, 582 days after the submission was received.
What is the product code of K220145?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.