HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310— 510(k) K053512

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K053512 for HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310, Substantially Equivalent on 2006-02-16. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 2005-12-16
Decision date: 2006-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.