510(k) Report

FDA applicant

K.E.P., LLC

North Attleboro, MA1 decision2004–20040 recalls

FDA records 1 decision for K.E.P., LLC (North Attleboro, MA) in 2004: 1 510(k) clearance. All are in product code KDJ (Set, Administration, For Peritoneal Dialysis…). No 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 K.E.P., LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for K.E.P., LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KDJSet, Administration, For Peritoneal Dialysis, Disposable1decision

What has FDA decided for it lately?

  • K042900K.E.P. Connector and ClipK.E.P., LLC · 2004

The one decision as K.E.P., LLC →