FKT — System, Dialysate Delivery, Sorbent Regenerated Class II
FDA product code FKT covers "System, Dialysate Delivery, Sorbent Regenerated", a Class II medical device regulated under 21 CFR 876.5600. Submissions are reviewed by the Gastroenterology, Urology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- FKT
- Device Class
- Class II
- Regulation Number
- 876.5600
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123835 | Renal Solutions | 2008 HEMODIALYSIS SORBENT SYSTEM | Feb 15, 2013 |
| K093362 | Renal Solutions | 2008 HEMODIALYSIS SORBENT SYSTEM | Aug 13, 2010 |
| K070739 | Renal Solutions | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | May 25, 2007 |
| K060381 | Renal Solutions | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | May 24, 2006 |
| K043574 | Renal Solutions | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Jun 3, 2005 |
| K031099 | Renal Solutions | SORB+HISORB+CARTRIDGE | Sep 17, 2003 |
| K954623 | Gambro Healthcare | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE… | Aug 28, 1996 |
| K882428 | Organon Teknika | REDY 2000 | Oct 25, 1988 |
| K874137 | Ash Medical Systems | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Apr 8, 1988 |
| K870270 | Ash Medical Systems | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Feb 25, 1987 |
| K864179 | Ash Medical Systems | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Dec 11, 1986 |
| K851188 | Organon Teknika | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - | Apr 12, 1985 |
| K842513 | Organon Teknika | HEMOPERFUSION PROCEDURE W/REDY 2000 | Sep 12, 1984 |
| K813574 | Organon Teknika | SORB II | Mar 23, 1982 |
| K812869 | Organon Teknika | D-3260 SORBENT CARTRIDGE | Dec 8, 1981 |
| K811170 | Organon Teknika | D-3160 SORBENT CARTRIDGE | Jul 31, 1981 |
| K801440 | Organon Teknika | SORB 10 DIALYSATE INFUSATE C1 INFUSATE | Jul 21, 1980 |
| K801385 | Organon Teknika | K1 POTASSIUM ACETATE ADDITIVE | Jul 21, 1980 |
| K792137 | Organon Teknika | SORB SYSTEM URS | Jan 16, 1980 |