Oneview Interface
FDA 510(k) K040074 · Nxstage Medical, Inc.
510(k) numberK040074
Submission
- Device name
- Oneview Interface
- Applicant
- Nxstage Medical, Inc.
Lawrence, MA, US - Received
- January 14, 2004
- Decision date
- April 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Fresenius USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)KDI · Traditional | 03/14/2024SE |
| K233213 | NxStage PureFlow SolutionKPO · Traditional | 01/18/2024SE |
| K230632 | VersiHD with GuideMe softwareKDI · Traditional | 08/11/2023SE |
| K183158 | NxStage Cartridge Express with SpeedswapKDI · Traditional | 08/09/2019SE |
| K181991 | NxStage Connected Health SystemFKP · Traditional | 09/26/2018SE |
| K171331 | NxStage System OneKDI · Traditional | 08/24/2017SE |
| K170469 | NxStage System One PlusKDI · Traditional | 05/09/2017SE |
| K150472 | NxStage System OneODN · Special | 06/04/2015SE |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) CartridgeKDI · Traditional | 03/20/2015SE |
| K141752 | Nxstage System OneODN · Traditional | 12/19/2014SE |
Questions and answers
When was Oneview Interface cleared by the FDA?
Oneview Interface (K040074) received a 510(k) decision of Substantially Equivalent on April 8, 2004, 85 days after the submission was received.
What is the product code of K040074?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.