Fresenius Liberty Select Cycler
FDA 510(k) K171652 · Fresenius Medical Care Renal Therapies Group, LLC
510(k) numberK171652
Submission
- Device name
- Fresenius Liberty Select Cycler
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
Waltham, MA, US - Received
- June 5, 2017
- Decision date
- September 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional | Simergent, LLC | 10/02/2025SE |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional | Byonyks Pvt, Ltd. | 05/16/2025SE |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional | Iren-Medical, Ltd. | 12/29/2022SE |
| K222318 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/31/2022SE |
| K212522 | Lilliput APD SystemFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2022SE |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional | Cloudcath | 02/09/2022SE |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional | Baxter Healthcare Corporation | 11/19/2020SE |
| K181108 | Fresenius Liberty Select CyclerFKX · Special | Fresenius Medical Care Renal Therapies Group, LLC | 05/24/2018SE |
| K173718 | Liberty Cycler SetFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/01/2018SE |
| K151525 | Amia Automated PD System with SharesourceFKX · Traditional | Deka Research and Development | 10/09/2015SE |
More from Deka Research and Development
| 510(k) | Device | Decision |
|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | 05/15/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | 02/10/2026SE |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO · Traditional | 01/29/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | 12/18/2025SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | 11/24/2025SE |
| K250471 | AquaC UNO HFIP · Traditional | 11/14/2025SE |
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | 10/09/2025SE |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…KPO · Traditional | 09/09/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | 06/13/2025SE |
Questions and answers
When was Fresenius Liberty Select Cycler cleared by the FDA?
Fresenius Liberty Select Cycler (K171652) received a 510(k) decision of Substantially Equivalent on September 15, 2017, 102 days after the submission was received.
What is the product code of K171652?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.