510(k) Report

FDA applicant

Germ Terminator Corporation

Concord, MA1 decision2002–20021 recall

FDA records 1 decision for Germ Terminator Corporation (Concord, MA) in 2002: 1 510(k) clearance. All are in product code MCF (Unit, Ultraviolet Sanitation/Sterilization…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, dental panel, where it files most

How often FDA has decided Germ Terminator Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Germ Terminator Corporation since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Germ Terminator Corporation 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?

  • MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K021258Germ Terminator GT 100 Toothbrush SanitizerGerm Terminator Corporation · 20021 recall

The one decision as Germ Terminator Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021258Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ…Apr 5, 2016Class II