Dual Spray Minispacer
FDA 510(k) K955805 · Thayer Medical Corp.
510(k) numberK955805
Submission
- Device name
- Dual Spray Minispacer
- Applicant
- Thayer Medical Corp.
Tucson, AZ, US - Received
- December 22, 1995
- Decision date
- March 21, 1996
- 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
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 |
|---|---|---|
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | 06/18/2024SE |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberNVP · Traditional | 04/01/2022SE |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberNVP · Traditional | 05/19/2017SE |
| K111570 | Minispacer(R) Mdi Adapter with Counter Incrementing ActuatorCAF · Traditional | 09/29/2011SE |
| K102658 | Minispacer Dual-Spray Mdi Adapter with 22MM (or 15MM) Od / 22MM Od/Id Connections / 15MM…CAF · Special | 12/10/2010SE |
| K993101 | LiteaireCAF · Traditional | 10/26/2000SE |
| K992722 | PrimeaireCAF · Traditional | 11/10/1999SE |
| K972237 | Hand Held MedispacerCAF · Traditional | 07/31/1997SE |
| K941026 | Thayer Mask to Mouthpiece Adapter/ConnectorBZA · Traditional | 08/18/1994SE |
| K924535 | Thayer Hand Held M.K.I. Holding ChamberCAF · Traditional | 03/10/1993SE |
Questions and answers
When was Dual Spray Minispacer cleared by the FDA?
Dual Spray Minispacer (K955805) received a 510(k) decision of Substantially Equivalent on March 21, 1996, 90 days after the submission was received.
What is the product code of K955805?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.