Comp A-I-R
FDA 510(k) K110860 · Omron Healthcare, Inc.
510(k) numberK110860
Submission
- Device name
- Comp A-I-R
- Applicant
- Omron Healthcare, Inc.
Bonita Springs, FL, US - Received
- March 29, 2011
- Decision date
- September 2, 2011
- 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 |
|---|---|---|
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| K183215 | Focus TENS Therapy, Model PM710-M/-LNUH · Traditional | 09/07/2019SE |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure MonitorDXN · Special | 04/17/2019SE |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKGDXN · Traditional | 03/14/2019SE |
| K182120 | Maxpower ReliefNUH · Traditional | 01/10/2019SE |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure MonitorDXN · Traditional | 11/09/2018SE |
| K181992 | Heat Pain ProNUH · Traditional | 11/09/2018SE |
| K182166 | Wrist Blood Pressure Monitor Model BP4350DXN · Traditional | 11/08/2018SE |
| K182127 | Wrist Blood Pressure Monitor Model BP6100DXN · Traditional | 11/02/2018SE |
Questions and answers
When was Comp A-I-R cleared by the FDA?
Comp A-I-R (K110860) received a 510(k) decision of Substantially Equivalent on September 2, 2011, 157 days after the submission was received.
What is the product code of K110860?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.