510(k) Report

FDA applicant

Saat, Ltd.

Crofton, MD3 decisions2001–20040 recalls

FDA records 3 decisions for Saat, Ltd. (Crofton, MD) from 2001 to 2004: 3 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Saat, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Saat, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Saat, Ltd. 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 Thermometer3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K002712Thermo Tek IR Forehead Thermometer, Model 718FSaat, Ltd. · 20013cite it
  • K010502Model Thermo Tek QuickcareSaat, Ltd. · 20011cites it

What has FDA decided for it lately?

  • K041646Thermotek Q5Saat, Ltd. · 2004
  • K010502Model Thermo Tek QuickcareSaat, Ltd. · 2001
  • K002712Thermo Tek IR Forehead Thermometer, Model 718FSaat, Ltd. · 2001

All 3 as Saat, Ltd. →