HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469— 510(k) K012988

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K012988 for HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469, Substantially Equivalent on 2001-12-05. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-06
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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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.