Product code FKT— Gastroenterology, Urology
2008 HEMODIALYSIS SORBENT SYSTEM
- Classification name
- System, Dialysate Delivery, Sorbent Regenerated
- Device class
- Class 2
- Regulation
- 21 CFR 876.5600
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code FKT
FDA has cleared devices under product code FKT between 1980 and 2013, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2013
- 2010
- 2007
- 2006
- 2005
- 2003
- 1996
- 1988
- 1987
- 1986
- 1985
- 1984
- 1982
- 1981
- 1980
Top applicants under product code FKT
Recent clearances under product code FKT
- K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM
- K093362 — 2008 HEMODIALYSIS SORBENT SYSTEM
- K070739 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
- K060381 — ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
- K043574 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
- K031099 — SORB+HISORB+CARTRIDGE
- K954623 — REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
- K882428 — REDY 2000
- K874137 — MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR
- K870270 — MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
- K864179 — BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR
- K851188 — PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
- K842513 — HEMOPERFUSION PROCEDURE W/REDY 2000
- K813574 — SORB II
- K812869 — D-3260 SORBENT CARTRIDGE
- K811170 — D-3160 SORBENT CARTRIDGE
- K801385 — K1 POTASSIUM ACETATE ADDITIVE
- K801440 — SORB 10 DIALYSATE INFUSATE C1 INFUSATE
- K792137 — SORB SYSTEM URS
Data sourced from openFDA. This site is unofficial and independent of the FDA.