Atlas FDA

FKT

19 FDA 510(k) clearances · Product code

86 daysmedian time to decision
289 days90th percentile
19clearances measured

FDA profile

Official device name
System, Dialysate Delivery, Sorbent Regenerated
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5600
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
1993: 2 · 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
2008 HEMODIALYSIS SORBENT SYSTEM (K123835)Renal Solutions, Inc.2013-02-15
2008 HEMODIALYSIS SORBENT SYSTEM (K093362)Renal Solutions, Inc.2010-08-13
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (K070739)Renal Solutions, Inc.2007-05-25
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 (K060381)Renal Solutions, Inc.2006-05-24
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (K043574)Renal Solutions, Inc.2005-06-03
SORB+HISORB+CARTRIDGE (K031099)Renal Solutions, Inc.2003-09-17
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) (K954623)Gambro Healthcare1996-08-28
REDY 2000 (K882428)Organon Teknika Corp.1988-10-25
MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (K874137)Ash Medical Systems, Inc.1988-04-08
MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (K870270)Ash Medical Systems, Inc.1987-02-25
BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR (K864179)Ash Medical Systems, Inc.1986-12-11
PACKETS FOR PREP. OF DIALYSATES & INFUSATES - (K851188)Organon Teknika Corp.1985-04-12
HEMOPERFUSION PROCEDURE W/REDY 2000 (K842513)Organon Teknika Corp.1984-09-12
SORB II (K813574)Organon Teknika Corp.1982-03-23
D-3260 SORBENT CARTRIDGE (K812869)Organon Teknika Corp.1981-12-08
D-3160 SORBENT CARTRIDGE (K811170)Organon Teknika Corp.1981-07-31
K1 POTASSIUM ACETATE ADDITIVE (K801385)Organon Teknika Corp.1980-07-21
SORB 10 DIALYSATE INFUSATE C1 INFUSATE (K801440)Organon Teknika Corp.1980-07-21
SORB SYSTEM URS (K792137)Organon Teknika Corp.1980-01-16

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Every clearance here is in the API, with alerts when new ones post.