Prisma System
FDA 510(k) K010805 · Gambro Renal Products
510(k) numberK010805
Submission
- Device name
- Prisma System
- Applicant
- Gambro Renal Products
Lakewood, CO, US - Received
- March 16, 2001
- Decision date
- August 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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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| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| 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 |
|---|---|---|
| K133807 | Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional | 03/26/2014SE |
| K131516 | Prismaflex System 7.10KDI · Traditional | 01/03/2014SE |
| K130039 | Revaclear 300 Dialyzer, Revaclear 400 DialyzerKDI · Traditional | 05/02/2013SE |
| K113313 | Molecular Adsorbent Recirculating(Mars)FLD · Traditional | 12/14/2012SE |
| K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyKPO · Traditional | 05/25/2012SE |
| K110823 | PrismaflexKDI · Traditional | 06/17/2011SE |
| K103832 | Phoenix Hemodialysis Delivery SystemKDI · Traditional | 05/20/2011SE |
| K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…MPB · Traditional | 12/21/2010SE |
| K100364 | Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520FJK · Traditional | 11/03/2010SE |
| K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 HFIP · Traditional | 07/29/2010SE |
Questions and answers
When was Prisma System cleared by the FDA?
Prisma System (K010805) received a 510(k) decision of Substantially Equivalent on August 6, 2002, 508 days after the submission was received.
What is the product code of K010805?
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.