Product Code: FKT
FDA class 2
21 CFR 876.5600
System, Dialysate Delivery, Sorbent Regenerated
Gastroenterology, Urology
The Sorbent Regenerated Dialysate Delivery System is a hemodialysis device that uses sorbent technology to regenerate spent dialysate for reuse, enabling dialysis without requiring a large supply of purified water. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKT, regulated under 21 CFR 876.5600 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.
510(k)s
19
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
33
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Basic Information
- Product Code
- FKT
- Device Class
- FDA class 2
- Regulation Number
- 876.5600
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Feb 15, 2013 | Substantially Equivalent | Renal Solutions, Inc. |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Aug 13, 2010 | Substantially Equivalent | Renal Solutions, Inc. |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | May 25, 2007 | Substantially Equivalent | Renal Solutions, Inc. |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | May 24, 2006 | Substantially Equivalent | Renal Solutions, Inc. |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Jun 03, 2005 | Substantially Equivalent | Renal Solutions, Inc. |
| K031099 | SORB+HISORB+CARTRIDGE | Sep 17, 2003 | Substantially Equivalent | Renal Solutions, Inc. |
| K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) | Aug 28, 1996 | Substantially Equivalent | Gambro Healthcare |
| K882428 | REDY 2000 | Oct 25, 1988 | Substantially Equivalent | Organon Teknika Corp. |
| K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Apr 08, 1988 | Substantially Equivalent | Ash Medical Systems, Inc. |
| K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Feb 25, 1987 | Substantially Equivalent | Ash Medical Systems, Inc. |
| K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Dec 11, 1986 | Substantially Equivalent | Ash Medical Systems, Inc. |
| K851188 | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - | Apr 12, 1985 | Substantially Equivalent | Organon Teknika Corp. |
| K842513 | HEMOPERFUSION PROCEDURE W/REDY 2000 | Sep 12, 1984 | Substantially Equivalent | Organon Teknika Corp. |
| K813574 | SORB II | Mar 23, 1982 | Substantially Equivalent | Organon Teknika Corp. |
| K812869 | D-3260 SORBENT CARTRIDGE | Dec 08, 1981 | Substantially Equivalent | Organon Teknika Corp. |
| K811170 | D-3160 SORBENT CARTRIDGE | Jul 31, 1981 | Substantially Equivalent | Organon Teknika Corp. |
| K801440 | SORB 10 DIALYSATE INFUSATE C1 INFUSATE | Jul 21, 1980 | Substantially Equivalent | Organon Teknika Corp. |
| K801385 | K1 POTASSIUM ACETATE ADDITIVE | Jul 21, 1980 | Substantially Equivalent | Organon Teknika Corp. |
| K792137 | SORB SYSTEM URS | Jan 16, 1980 | Substantially Equivalent | Organon Teknika Corp. |