510(k) Report

FDA applicant

Trutek, Inc.

Crofton, MD2 decisions2003–20060 recalls

FDA records 2 decisions for Trutek, Inc. (Crofton, MD) from 2003 to 2006: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and NUP (Cream, Nasal, Topical, Mechanical Allergen…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Trutek Corp”.

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 Trutek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trutek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trutek, 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?

  • FLLContinuous Measurement Thermometer1decision
  • NUPCream, Nasal, Topical, Mechanical Allergen Particle Barrier1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 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.

  • K053625NasalguardTrutek Corp · 20062cite it

What has FDA decided for it lately?

  • K053625NasalguardTrutek Corp · 2006
  • K023510Trutek Select Model TT-1001Trutek, Inc. · 2003

The one decision as Trutek, Inc. →The one decision as Trutek Corp →