510(k) Report

FDA applicant

Tenghi Co., Ltd.

Taichung, TW2 decisions2001–20030 recalls

FDA records 2 decisions for Tenghi Co., Ltd. (Taichung, TW) from 2001 to 2003: 2 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 0 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 Tenghi Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tenghi Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tenghi Co., 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 Thermometer2decisions

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 1 time; 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.

  • K010383Temp ScanTenghi Co., Ltd. · 20011cites it

What has FDA decided for it lately?

  • K033069Digital Temperature Monitor, Model GT-202, GT-203, GT-204, and GT-205Tenghi Co., Ltd. · 2003
  • K010383Temp ScanTenghi Co., Ltd. · 2001

All 2 as Tenghi Co., Ltd. →