PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB— 510(k) K010131

Name: FDA 510(k) clearance K010131
Creator: U.S. Food and Drug Administration
Published: 2002-03-26

Substantially Equivalent

Aksys, Ltd.

FDA 510(k) clearance K010131 for PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB, Substantially Equivalent on 2002-03-26. Applicant: Aksys, Ltd.. Device class: 2.

Clearance details

Applicant: Aksys, Ltd.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2001-01-16
Decision date: 2002-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.