Manifold & Nebulizer, Universal
FDA 510(k) K772068 · Inspiron Corp.
510(k) numberK772068
Submission
- Device name
- Manifold & Nebulizer, Universal
- Applicant
- Inspiron Corp.
Walker, MI, US - Received
- November 1, 1977
- Decision date
- November 15, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K860838 | Inspiron Double Swivel Trach AdapterBZA · Traditional | 04/09/1986SE |
| K850346 | Oxygen ConcentratorCAW · Traditional | 02/04/1985SE |
| K843932 | Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional | 10/18/1984SE |
| K840935 | Manual Resuscitation SystemBTM · Traditional | 04/05/1984SE |
| K841158 | Nebulo 28 Nebulizer KitBTT · Traditional | 03/30/1984SE |
| K840418 | Inspiratory/Expiratory Muscle ExercisBWF · Traditional | 02/17/1984SE |
| K834290 | Inspiron Liquid Oxygen SystemBYJ · Traditional | 02/04/1984SE |
| K772072 | Manifold & Nebu. for Doub. Line Mach.CAF · Traditional | 11/15/1977SE |
| K772071 | Manifold & Nebu. for Single Line Mach.CAF · Traditional | 11/15/1977SE |
| K772070 | Ventilator Setup, VolumeCAF · Traditional | 11/15/1977SE |
Questions and answers
When was Manifold & Nebulizer, Universal cleared by the FDA?
Manifold & Nebulizer, Universal (K772068) received a 510(k) decision of Substantially Equivalent on November 15, 1977, 14 days after the submission was received.
What is the product code of K772068?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.