510(k) Report

FDA applicant

Certol International, LLC

Boulder, CO1 decision2005–20050 recalls

FDA records 1 decision for Certol International, LLC (Boulder, CO) in 2005: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Certol International, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Certol International, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Certol International, 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?

  • FMINeedle, Hypodermic, Single Lumen1decision

What has FDA decided for it lately?

  • K052725Protector Needle Sheath PropCertol International, LLC · 2005

The one decision as Certol International, LLC →