Mdi Adaptor
FDA 510(k) K900783 · Hudson Oxygen Therapy Sales Co.
510(k) numberK900783
Submission
- Device name
- Mdi Adaptor
- Applicant
- Hudson Oxygen Therapy Sales Co.
Temecula, CA, US - Received
- February 20, 1990
- Decision date
- July 18, 1990
- 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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| 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 |
|---|---|---|
| K902062 | Peep ValveBYE · Traditional | 09/04/1990SE |
| K900470 | In-The NebulizerCAF · Traditional | 05/18/1990SE |
| K895589 | Manual ResuscitatorBTM · Traditional | 03/30/1990SE |
| K896136 | Infant C.P.A.P. MonitorCAP · Traditional | 01/09/1990SE |
| K895747 | Ventilarm II Portable Airway Pressure MonitorCAP · Traditional | 10/27/1989SE |
| K895231 | Catalog No. 1755 1S0-NEB, a Filtered NebulizerCAF · Traditional | 10/27/1989SE |
| K890035 | Bacteria FilterCAH · Traditional | 05/05/1989SE |
| K870895 | No. 1552, Valved Venti-CompCBP · Traditional | 05/04/1987SE |
| K871157 | C.P.A.P. Nasal CannulaBZD · Traditional | 04/21/1987SE |
| K870138 | 1160 Simple Isolation Valve & 1161 Filtered ValveCBP · Traditional | 03/06/1987SE |
Questions and answers
When was Mdi Adaptor cleared by the FDA?
Mdi Adaptor (K900783) received a 510(k) decision of Substantially Equivalent on July 18, 1990, 148 days after the submission was received.
What is the product code of K900783?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.