Invacare Pro, Compact and Portable Desktop
FDA 510(k) K042483 · Invacare Corporation
510(k) numberK042483
Submission
- Device name
- Invacare Pro, Compact and Portable Desktop
- Applicant
- Invacare Corporation
Elyria, OH, US - Received
- September 13, 2004
- Decision date
- January 6, 2005
- 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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| 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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| K200890 | Invacare Perfecto2V Oxygen ConcentratorCAW · Traditional | 08/06/2020SE |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPITI · Traditional | 01/02/2020SE |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder…CAW · Traditional | 08/29/2019SE |
| K182946 | Invacare TDX SP2-HD with Captain's SeatITI · Special | 12/11/2018SE |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR · Traditional | 11/14/2018SE |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…ITI · Traditional | 07/12/2017SE |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…IOR · Traditional | 04/17/2017SE |
| K162696 | Kuschall Advance Manual WheelchairIOR · Traditional | 12/28/2016SE |
Questions and answers
When was Invacare Pro, Compact and Portable Desktop cleared by the FDA?
Invacare Pro, Compact and Portable Desktop (K042483) received a 510(k) decision of Substantially Equivalent on January 6, 2005, 115 days after the submission was received.
What is the product code of K042483?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.