NxStage Connected Health System
FDA 510(k) K181991 · Nxstage Medical, Inc.
510(k) numberK181991
Submission
- Device name
- NxStage Connected Health System
- Applicant
- Nxstage Medical, Inc.
Lawrence, MA, US - Received
- July 26, 2018
- Decision date
- September 26, 2018
- 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
Other 510(k)s with product code FKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131739 | Nxstage Connected Health SystemFKP · Traditional | Nxstage Medical, Inc. | 10/10/2013SE |
| K130460 | Nxstage Dosing CalculatorFKP · Traditional | Nxstage Medical, Inc. | 07/11/2013SE |
| K040074 | Oneview InterfaceFKP · Traditional | Nxstage Medical, Inc. | 04/08/2004SE |
| K021060 | Fresenius Icare Monitoring SystemFKP · Traditional | Fresenius Medical Care North America | 11/13/2002SE |
| K003615 | Sterichek Sensitive-Feed Water and Rinse Water Reagent StripsFKP · Special | Environmental Test Systems, Inc. | 02/01/2001SE |
| K992255 | Ckhemo, Model Ckhemo Version 1.0FKP · Traditional | Csam, Inc. | 11/30/1999SE |
| K964264 | High Range Peroxide Test StripFKP · Traditional | Integrated Biomedical Technology, Inc. | 06/16/1997SE |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | Fresenius USA, Inc. | 06/13/1996SE |
| K953854 | Watercheck Reagent Strip for Chlorine & PeroxideFKP · Traditional | Integrated Biomedical Technology, Inc. | 03/11/1996SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | Fresenius USA, Inc. | 11/29/1995SE |
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 |
| 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 |
| K134019 | Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…FIE · Traditional | 09/11/2014SE |
Questions and answers
When was NxStage Connected Health System cleared by the FDA?
NxStage Connected Health System (K181991) received a 510(k) decision of Substantially Equivalent on September 26, 2018, 62 days after the submission was received.
What is the product code of K181991?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.