510(k) Report

FDA applicant

Nirvi Intl. USA

Pittsburg, PA1 decision2001–20010 recalls

FDA records 1 decision for Nirvi Intl. USA (Pittsburg, PA) in 2001: 1 510(k) clearance. All are in product code LRS (I.V. Start Kit). 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, general hospital panel, where it files most

How often FDA has decided Nirvi Intl. USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nirvi Intl. USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nirvi Intl. USA 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?

  • LRSI.V. Start Kit1decision

What has FDA decided for it lately?

  • K001879Infusion IV SetNirvi Intl. USA · 2001

The one decision as Nirvi Intl. USA →