Venofer Pump
FDA 510(k) K093964 · Renal Solutions, Inc.
510(k) numberK093964
Submission
- Device name
- Venofer Pump
- Applicant
- Renal Solutions, Inc.
Warrendale, PA, US - Received
- December 24, 2009
- Decision date
- July 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 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 |
| K093362 | 2008 Hemodialysis Sorbent SystemFKT · Abbreviated | 08/13/2010SE |
| 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 Venofer Pump cleared by the FDA?
Venofer Pump (K093964) received a 510(k) decision of Substantially Equivalent on July 9, 2010, 197 days after the submission was received.
What is the product code of K093964?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.