FKT · System, Dialysate Delivery, Sorbent Regenerated
Gastroenterology, Urology · 21 CFR 876.5600 · Class 2
Overview
| Product Code | FKT |
|---|---|
| Device Name | System, Dialysate Delivery, Sorbent Regenerated |
| Regulation | 21 CFR 876.5600 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
Identification
A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | Feb 15, 2013 | SESE |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | Aug 13, 2010 | SESE |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | Renal Solutions, Inc. | May 25, 2007 | SESE |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | Renal Solutions, Inc. | May 24, 2006 | SESE |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Renal Solutions, Inc. | Jun 3, 2005 | SESE |
| K031099 | SORB+HISORB+CARTRIDGE | Renal Solutions, Inc. | Sep 17, 2003 | SESE |
| K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) | Gambro Healthcare | Aug 28, 1996 | SESE |
| K882428 | REDY 2000 | Organon Teknika Corp. | Oct 25, 1988 | SESE |
| K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Ash Medical Systems, Inc. | Apr 8, 1988 | SESE |
| K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Ash Medical Systems, Inc. | Feb 25, 1987 | SESE |
| K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Ash Medical Systems, Inc. | Dec 11, 1986 | SESE |
| K851188 | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - | Organon Teknika Corp. | Apr 12, 1985 | SESE |
| K842513 | HEMOPERFUSION PROCEDURE W/REDY 2000 | Organon Teknika Corp. | Sep 12, 1984 | SESE |
| K813574 | SORB II | Organon Teknika Corp. | Mar 23, 1982 | SESE |
| K812869 | D-3260 SORBENT CARTRIDGE | Organon Teknika Corp. | Dec 8, 1981 | SESE |
| K811170 | D-3160 SORBENT CARTRIDGE | Organon Teknika Corp. | Jul 31, 1981 | SESE |
| K801440 | SORB 10 DIALYSATE INFUSATE C1 INFUSATE | Organon Teknika Corp. | Jul 21, 1980 | SESE |
| K801385 | K1 POTASSIUM ACETATE ADDITIVE | Organon Teknika Corp. | Jul 21, 1980 | SESE |
| K792137 | SORB SYSTEM URS | Organon Teknika Corp. | Jan 16, 1980 | SESE |
Top Applicants
- Organon Teknika Corp. — 9 clearances
- Renal Solutions, Inc. — 6 clearances
- Ash Medical Systems, Inc. — 3 clearances
- Gambro Healthcare — 1 clearance
