Nxstage Pureflow SL
FDA 510(k) K080919 · Nxstage Medical, Inc.
510(k) numberK080919
Submission
- Device name
- Nxstage Pureflow SL
- Applicant
- Nxstage Medical, Inc.
Lawrence, MA, US - Received
- April 1, 2008
- Decision date
- October 15, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKR – Subsystem, Proportioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K043436 | Nxstage Dialysate Preparation Module, Model NX0269FKR · Traditional | Nxstage Medical, Inc. | 03/17/2005SE |
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| 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 Nxstage Pureflow SL cleared by the FDA?
Nxstage Pureflow SL (K080919) received a 510(k) decision of Substantially Equivalent on October 15, 2008, 197 days after the submission was received.
What is the product code of K080919?
The FDA product code is FKR – Subsystem, Proportioning, a Class II (moderate risk) device regulated under 21 CFR 876.5820.