Standard Nebulizer Heater
FDA 510(k) K926280 · Professional Medical Products, Inc.
510(k) numberK926280
Submission
- Device name
- Standard Nebulizer Heater
- Applicant
- Professional Medical Products, Inc.
Ashland, VA, US - Received
- December 14, 1992
- Decision date
- March 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K930270 | Patient Preoperative Prep Tray, Single UseLRO · Traditional | 02/17/1994SE |
| K920292 | Various Kits and TraysLRO · Traditional | 01/26/1994SEKD |
| K862010 | Chick Surgical LightFTA · Traditional | 06/09/1986SE |
| K860739 | Chick Surigical LightFSY · Traditional | 03/28/1986SE |
| K834478 | Chick/Reison Patient Emerg. TrolleyKXJ · Traditional | 02/21/1984SE |
| K830825 | Yield Non-Adherent DressingFRO · Traditional | 05/13/1983SE |
| K822713 | Derm-A-Tec Skin Barrier Film · Traditional | 12/07/1982SE |
| K820413 | Aegis Non-Adherent DressingNAB · Traditional | 03/12/1982SE |
Questions and answers
When was Standard Nebulizer Heater cleared by the FDA?
Standard Nebulizer Heater (K926280) received a 510(k) decision of Substantially Equivalent on March 22, 1994, 463 days after the submission was received.
What is the product code of K926280?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.