Renaflo Hemoconcentrator
FDA 510(k) K844790 · Renal Systems, Inc.
510(k) numberK844790
Submission
- Device name
- Renaflo Hemoconcentrator
- Applicant
- Renal Systems, Inc.
Minneapolis, MN, US - Received
- December 10, 1984
- Decision date
- May 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code KDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| 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 |
|---|---|---|
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | 01/05/1998SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | 06/09/1987SE |
| K854011 | Renalfo Hemofilter CavhdKDI · Traditional | 11/05/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | 01/07/1985SE |
| K843963 | Dialysate Concentrate for Hemodialysis-Liquid/PowdFKQ · Traditional | 01/07/1985SE |
| K842258 | RenatronLIF · Traditional | 07/06/1984SE |
| K841543 | Concentrate Conductivity MeterFKQ · Traditional | 05/22/1984SE |
| K840182 | Renapak Concentrate Mixing Sys.FKQ · Traditional | 05/02/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | 02/21/1984SE |
| K840436 | Hemasite/Renaloy -Vascular Access ShuntFIQ · Traditional | 02/21/1984SE |
Questions and answers
When was Renaflo Hemoconcentrator cleared by the FDA?
Renaflo Hemoconcentrator (K844790) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 164 days after the submission was received.
What is the product code of K844790?
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.