Fresenius Liberty Cycler
FDA 510(k) K043363 · Fresenius Medical Care North America
510(k) numberK043363
Submission
- Device name
- Fresenius Liberty Cycler
- Applicant
- Fresenius Medical Care North America
Lexington, MA, US - Received
- December 7, 2004
- Decision date
- March 31, 2005
- 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 |
| K171652 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/15/2017SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252181 | AquaAFIP · Traditional | 09/09/2025SE |
| K162488 | Optiflux dialyzerKDI · Traditional | 04/06/2017SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | 11/05/2015SE |
| K152367 | Optiflux dialyzerKDI · Traditional | 10/29/2015SE |
| K123262 | Optiflux Ultra DialyzerKDI · Traditional | 01/06/2014SE |
| K131611 | Fresenius Dry Acid Dissolution UnitsKPO · Traditional | 08/29/2013SE |
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | 07/03/2013SE |
| K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemKDI · Traditional | 12/06/2012SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | 11/09/2012SE |
| K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemKDI · Special | 02/02/2012SE |
Questions and answers
When was Fresenius Liberty Cycler cleared by the FDA?
Fresenius Liberty Cycler (K043363) received a 510(k) decision of Substantially Equivalent on March 31, 2005, 114 days after the submission was received.
What is the product code of K043363?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.