510(k) Report

FDA applicant

Emergogroup, Inc.

Clearwater, FL2 decisions2004–20050 recalls

FDA records 2 decisions for Emergogroup, Inc. (Clearwater, FL) from 2004 to 2005: 2 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and HFX (Clamp, Circumcision). 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 Emergogroup, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emergogroup, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Emergogroup, Inc. 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
  • HFXClamp, Circumcision1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K032091Smart Klamp Various by SizeEmergogroup, Inc. · 20044cite it
  • K042917Stat Medical Pen NeedleEmergogroup, Inc. · 20051cites it

What has FDA decided for it lately?

  • K042917Stat Medical Pen NeedleEmergogroup, Inc. · 2005
  • K032091Smart Klamp Various by SizeEmergogroup, Inc. · 2004

All 2 as Emergogroup, Inc. →