2008 Hemodialysis Sorbent System
FDA 510(k) K093362 · Renal Solutions, Inc.
510(k) numberK093362
Submission
- Device name
- 2008 Hemodialysis Sorbent System
- Applicant
- Renal Solutions, Inc.
Warrendale, PA, US - Received
- October 28, 2009
- Decision date
- August 13, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKT – System, Dialysate Delivery, Sorbent Regenerated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5600
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123835 | 2008 Hemodialysis Sorbent SystemFKT · Special | Renal Solutions, Inc. | 02/15/2013SE |
| K070739 | Allient Sorbent Hemodialysis System, Model# 1500FKT · Special | Renal Solutions, Inc. | 05/25/2007SE |
| K060381 | Allient Sorbet Hemodialysis System, Model 1100FKT · Special | Renal Solutions, Inc. | 05/24/2006SE |
| K043574 | Allient Sorbent Hemodialysis System, Model 1000FKT · Traditional | Renal Solutions, Inc. | 06/03/2005SE |
| K031099 | Sorb+Hisorb+CartridgeFKT · Traditional | Renal Solutions, Inc. | 09/17/2003SE |
| K954623 | Redy 2000 System (Therapeutic Plasma Exchange Option and Monitoring Line Y-Connector)FKT · Traditional | Gambro Healthcare | 08/28/1996SE |
| K882428 | Redy 2000FKT · Traditional | Organon Teknika Corp. | 10/25/1988SE |
| K874137 | Modified Biologic 1000 Hemodial. & HD-1000 Dis CarFKT · Traditional | Ash Medical Systems, Inc. | 04/08/1988SE |
| K870270 | Modified Bio. Hemodialysis & HD-1000 Disp. Cart.FKT · Traditional | Ash Medical Systems, Inc. | 02/25/1987SE |
| K864179 | Biologic 1000 Hemodialysis MACH/HD-1000 Disp CartrFKT · Traditional | Ash Medical Systems, Inc. | 12/11/1986SE |
More from Ash Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123835 | 2008 Hemodialysis Sorbent SystemFKT · Special | 02/15/2013SE |
| K121497 | Venofer PumpKDI · Traditional | 08/17/2012SE |
| K103564 | Venofer PumpKDI · Special | 02/10/2011SE |
| K093964 | Venofer PumpKDI · Abbreviated | 07/09/2010SE |
| K070739 | Allient Sorbent Hemodialysis System, Model# 1500FKT · Special | 05/25/2007SE |
| K060381 | Allient Sorbet Hemodialysis System, Model 1100FKT · Special | 05/24/2006SE |
| K043574 | Allient Sorbent Hemodialysis System, Model 1000FKT · Traditional | 06/03/2005SE |
| K031099 | Sorb+Hisorb+CartridgeFKT · Traditional | 09/17/2003SE |
Questions and answers
When was 2008 Hemodialysis Sorbent System cleared by the FDA?
2008 Hemodialysis Sorbent System (K093362) received a 510(k) decision of Substantially Equivalent on August 13, 2010, 289 days after the submission was received.
What is the product code of K093362?
The FDA product code is FKT – System, Dialysate Delivery, Sorbent Regenerated, a Class II (moderate risk) device regulated under 21 CFR 876.5600.