Proneb Max
FDA 510(k) K191270 · Pari Respiratory Equipment, Inc.
510(k) numberK191270
Submission
- Device name
- Proneb Max
- Applicant
- Pari Respiratory Equipment, Inc.
Midlothian, VA, US - Received
- May 13, 2019
- Decision date
- January 23, 2020
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K251572 | eRapid with eTrack SystemCAF · Traditional | 12/19/2025SE |
| K223840 | eRapid Nebulizer SystemCAF · Traditional | 08/11/2023SE |
| K162785 | Velox Nebulizer SystemCAF · Traditional | 04/14/2017SE |
| K150044 | O-PepBWF · Traditional | 05/27/2016SE |
| K112859 | Erapid Nebulizer SystemCAF · Traditional | 05/30/2012SE |
| K092560 | Pari SinusCAF · Traditional | 05/06/2010SE |
| K100380 | Altera Nebulizer System, Model 678G1002CAF · Traditional | 02/22/2010SE |
| K092918 | Pari ViosCAF · Traditional | 02/04/2010SE |
| K090829 | Pari Pep SBWF · Traditional | 07/21/2009SE |
Questions and answers
When was Proneb Max cleared by the FDA?
Proneb Max (K191270) received a 510(k) decision of Substantially Equivalent on January 23, 2020, 255 days after the submission was received.
What is the product code of K191270?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.