FDA applicant

Denco

Wilmington, DE1 decision1994–19940 recalls

FDA records 1 decision for Denco (Wilmington, DE) in 1994: 1 510(k) clearance. All are in product code KPF (System, Dialysate Delivery, Semi-Automatic…). 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 Denco’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Denco since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Denco

Which product codes does it file in?

What has FDA decided for it lately?