Subsystem, Proportioning
The Proportioning Subsystem is a component of a hemodialysis delivery system responsible for accurately mixing concentrate with purified water to achieve the correct dialysate composition. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKR, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.
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Basic Information
- Product Code
- FKR
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140571 | NXSTAGE PUREFLOW SL | May 15, 2014 | Substantially Equivalent | Nxstage Medical, Inc. |
| K111174 | NXSTAGE PUREFLOW SL | Sep 19, 2011 | Substantially Equivalent | Nxstage Medical, Inc. |
| K080919 | NXSTAGE PUREFLOW SL | Oct 15, 2008 | Substantially Equivalent | Nxstage Medical, Inc. |
| K060296 | NXSTAGE DIALYSATE PREPARATION MODULE | Mar 31, 2006 | Substantially Equivalent | Nxstage Medical, Inc. |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | Mar 17, 2005 | Substantially Equivalent | Nxstage Medical, Inc. |
| K850435 | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS | Jun 04, 1985 | Substantially Equivalent | Sartorius Filters, Inc. |
| K850756 | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | Mar 20, 1985 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K810605 | CHEMATIC BICARBONATE DIALYSATE SYSTEM | Jun 16, 1981 | Substantially Equivalent | Trimedyne, Inc. |
| K810127 | GAMBRO BICARBONATE MODULE, BCM-10 | Feb 25, 1981 | Substantially Equivalent | Gambro, Inc. |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | Nov 12, 1980 | Substantially Equivalent | Renal Systems, Inc. |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | May 14, 1980 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K781303 | BIO-PRO UNIT | Oct 02, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.