510(k) K102936 ยท FKX System, Peritoneal, Automatic Delivery
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Mar 30, 2011 |
| Received | Oct 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102936
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2018 | Baxter Healthcare Corporation L5C4531 X1
Integrated APD Set with Cassette 3-Prong
Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. Terminated |
FKX | None listed |
| Jul 5, 2017 | Baxter Healthcare Corporation HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R
Product Usage:
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the trea Terminated |
FKX | None listed |
| Jul 5, 2017 | Baxter Healthcare Corporation HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R
Product Usage:
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the Terminated |
FKX | None listed |
| Jan 19, 2017 | Baxter Healthcare Corporation APD Set with Cassette 3-Prong Peritoneal Dialysis Set
Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical an Terminated |
FKX | None listed |
| Nov 17, 2015 | Baxter Healthcare Corp. Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Terminated |
FKX | None listed |
| Mar 18, 2015 | Baxter Healthcare Corp. The HomeChoice Pro APD System is a peritoneal dialysis system.
The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange Terminated |
FKX | None listed |
| Mar 4, 2015 | Baxter Healthcare Corp. AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Terminated |
FIK | None listed |
| Feb 2, 2015 | Baxter Healthcare Corp. Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path.
Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide P Terminated |
FKX | None listed |
| Jan 29, 2015 | Baxter Healthcare Corp. HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474. Terminated |
FKX | None listed |
| Jan 7, 2015 | Baxter Healthcare Corp. HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's
HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediat Terminated |
FKX | None listed |
| Oct 7, 2013 | Baxter Healthcare Corp. 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter.
2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.