Nxstage Dialysate Preparation Module, Model NX0269
FDA 510(k) K043436 · Nxstage Medical, Inc.
510(k) numberK043436
Submission
- Device name
- Nxstage Dialysate Preparation Module, Model NX0269
- Applicant
- Nxstage Medical, Inc.
Lawrence, MA, US - Received
- December 13, 2004
- Decision date
- March 17, 2005
- 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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| K140571 | Nxstage Pureflow SLFKR · Special | Nxstage Medical, Inc. | 05/15/2014SE |
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| K080919 | Nxstage Pureflow SLFKR · Traditional | Nxstage Medical, Inc. | 10/15/2008SE |
| K060296 | Nxstage Dialysate Preparation ModuleFKR · Special | Nxstage Medical, Inc. | 03/31/2006SE |
| K850435 | Sartorius Aquasart SM 40035 - Dialysate SysFKR · Traditional | Sartorius Filters, Inc. | 06/04/1985SE |
| K850756 | Auto-D Automatic Disinfection Access/AttachmentsFKR · Traditional | Travenol Laboratories, S.A. | 03/20/1985SE |
| K810605 | Chematic Bicarbonate Dialysate SystemFKR · Traditional | Trimedyne, Inc. | 06/16/1981SE |
| K810127 | Gambro Bicarbonate Module, BCM-10FKR · Traditional | Gambro, Inc. | 02/25/1981SE |
| K802465 | Bicarb-O-Mate Hemodialysis Sod. Bicarb.FKR · Traditional | Renal Systems, Inc. | 11/12/1980SE |
| K800772 | Mod. DM-357 Bicarbonate Retrofit KitFKR · Traditional | Extracorporeal Medical Specialities, Inc. | 05/14/1980SE |
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| K170469 | NxStage System One PlusKDI · Traditional | 05/09/2017SE |
| K150472 | NxStage System OneODN · Special | 06/04/2015SE |
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Questions and answers
When was Nxstage Dialysate Preparation Module, Model NX0269 cleared by the FDA?
Nxstage Dialysate Preparation Module, Model NX0269 (K043436) received a 510(k) decision of Substantially Equivalent on March 17, 2005, 94 days after the submission was received.
What is the product code of K043436?
The FDA product code is FKR – Subsystem, Proportioning, a Class II (moderate risk) device regulated under 21 CFR 876.5820.