TABLO CARTRIDGE— 510(k) K140841

Substantially Equivalent

Home Dialysis Plus

FDA 510(k) clearance K140841 for TABLO CARTRIDGE, Substantially Equivalent on 2014-09-11. Applicant: Home Dialysis Plus.

Clearance details

Applicant: Home Dialysis Plus
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2014-04-02
Decision date: 2014-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.