FKX — System, Peritoneal, Automatic Delivery Class II
FDA product code FKX covers "System, Peritoneal, Automatic Delivery", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKX
- Device Class
- Class II
- Regulation Number
- 876.5630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250523 | simergent | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes S | October 2, 2025 |
| K243371 | byonyks pvt | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | May 16, 2025 |
| K220935 | iren-medical | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supe | December 29, 2022 |
| K222318 | fresenius medical care renal therapies group | Fresenius Liberty Select Cycler | October 31, 2022 |
| K212522 | fresenius medical care renal therapies group | Lilliput APD System | April 15, 2022 |
| K212658 | cloudcath | CloudCath Peritoneal Dialysis Drain Set Monitoring System | February 9, 2022 |
| K201867 | baxter healthcare corporation | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the | November 19, 2020 |
| K181108 | fresenius medical care renal therapies group | Fresenius Liberty Select Cycler | May 24, 2018 |
| K173718 | fresenius medical care renal therapies group | Liberty Cycler Set | May 1, 2018 |
| K171652 | fresenius medical care renal therapies group | Fresenius Liberty Select Cycler | September 15, 2017 |
| K151525 | deka research and development | Amia Automated PD System with Sharesource | October 9, 2015 |
| K141145 | fresenius medical care renal therapies group | LIBERTY PDX CYCLER | July 30, 2014 |
| K123630 | fresenius medical care north america, design cente | FRESENIUS LIBERTY CYCLER | September 9, 2013 |
| K124018 | deka research and development | AMIA AUTOMATED PD SYSTEM | June 14, 2013 |
| K103220 | deka research and development | VOYAGER PERITONEAL DIALYSIS SYSTEM | July 29, 2011 |
| K102936 | baxter healthcare | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM M | March 30, 2011 |
| K053512 | baxter healthcare | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4 | February 16, 2006 |
| K043363 | fresenius medical care north america | FRESENIUS LIBERTY CYCLER | March 31, 2005 |
| K012988 | baxter healthcare | HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C | December 5, 2001 |
| K002892 | fresenius medical care north america | FRSENIUS PD IQCARD CYCLER | April 5, 2001 |