510(k) K043363 ยท FKX System, Peritoneal, Automatic Delivery
FRESENIUS LIBERTY CYCLER
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Mar 31, 2005 |
| Received | Dec 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. 026-20036A Liberty Drain Line, Luer Tap
For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting Terminated |
FKX | None listed |
| Jan 27, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Liberty Cycler-Peritoneal Dialysis Cycler
Model: 180111 and RTLR180111 Terminated |
FKX | None listed |
| Nov 5, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler
Part Number: RTLR180111
Product Usage:
The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. Terminated |
FKX | None listed |
| Jul 10, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler Set Single Conn./Ext DL
Product Number: 050-87216
Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. Terminated |
FKX | None listed |
| Feb 11, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.
Acute and chronic peritoneal dialysis. Terminated |
FKX | None listed |
| Apr 24, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8.
The Fresenius Liberty Cycler is intended for acute or Terminated |
FKX | None listed |
| Oct 20, 2010 | Fresenius Medical Care Holdings, Inc. LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Terminated |
FKX | None listed |
| Oct 20, 2010 | Fresenius Medical Care Holdings, Inc. LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoz Terminated |
FKX | None listed |
| Oct 20, 2010 | Fresenius Medical Care Holdings, Inc. LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA b Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.