FKTClass IILife-sustaining
System, Dialysate Delivery, Sorbent Regenerated
Gastroenterology, Urology · 21 CFR 876.5600
MDR events7All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances19All time
Recent MDR events
7 adverse event reports on file
- 2008 SORBENT SYSTEMOct 12, 2012OtherRenal Solutions Inc.3005778453-2012-00001
- 2008 SORBENT SYSTEMDec 30, 2011InjuryRenal Solutions, Inc.3005778453-2011-00001
- 2008 SORBENT SYSTEMDec 14, 2010OtherRenal Solutions3005778453-2010-00001
- "REDY"Apr 17, 2008DeathMW5006289
- BIOLOGIC-DT SYSTEMNov 26, 1997InjuryHemocleanse, Inc.1835219-1997-00001
- SORB SYSTEMSep 8, 1993MalfunctionOrganon Teknika Corp.6717
- REDY SORBENT MACHINE #1Feb 2, 1993InjuryOrganon Teknika2777
Event type breakdown
Injury3
Other2
Death1
Malfunction1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
19 clearances for this product code
- Renal Solutions, Inc.Feb 15, 2013
K123835 · 2008 HEMODIALYSIS SORBENT SYSTEM
- Renal Solutions, Inc.Aug 13, 2010
K093362 · 2008 HEMODIALYSIS SORBENT SYSTEM
- Renal Solutions, Inc.May 25, 2007
K070739 · ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
- Renal Solutions, Inc.May 24, 2006
K060381 · ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
- Renal Solutions, Inc.Jun 3, 2005
K043574 · ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
- Renal Solutions, Inc.Sep 17, 2003
K031099 · SORB+HISORB+CARTRIDGE
- Gambro HealthcareAug 28, 1996
K954623 · REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
- Organon Teknika Corp.Oct 25, 1988
K882428 · REDY 2000