510(k) Report

FDA applicant

Aksys, Ltd.

Lincolnshire, IL1 decision2002–20021 recall

FDA records 1 decision for Aksys, Ltd. (Lincolnshire, IL) in 2002: 1 510(k) clearance. All are in product code KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 11 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Aksys, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aksys, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aksys, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aksys, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604…Aksys, Ltd. · 20025cite it

What has FDA decided for it lately?

  • K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604…Aksys, Ltd. · 20021 recall

The one decision as Aksys, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K010131Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high…Jun 26, 2006