510(k) Report

FDA applicant

Dni Nevada, Inc.

Carson City, NV1 decision2001–20010 recalls

FDA records 1 decision for Dni Nevada, Inc. (Carson City, NV) in 2001: 1 510(k) clearance. All are in product code DTC (Analyzer, Pacemaker Generator Function). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Dni Nevada, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dni Nevada, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dni Nevada, Inc.’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?

  • DTCAnalyzer, Pacemaker Generator Function1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K011729Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc. · 2001

The one decision as Dni Nevada, Inc. →