510(k) Report

FDA applicant

Truphatek International, Ltd.

Bonita Springs, FL2 decisions2006–20071 recall

FDA records 2 decisions for Truphatek International, Ltd. (Bonita Springs, FL) from 2006 to 2007: 2 510(k) clearances. Most are in product codes FFS (Image, Illumination, Fiberoptic, For Endoscope) and CCW (Laryngoscope, Rigid). Its devices cite 3 predicates, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Truphatek International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Truphatek International, 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?

  • FFSImage, Illumination, Fiberoptic, For Endoscope1decision
  • CCWLaryngoscope, Rigid1decision

Whose devices does it build on?

Its devices cite 3 predicates; 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.

  • K062523Tru-MR Laryngoscope SetTruphatek International, Ltd. · 20062cite it

What has FDA decided for it lately?

  • K063309Tru-CableTruphatek International, Ltd. · 2007
  • K062523Tru-MR Laryngoscope SetTruphatek International, Ltd. · 20061 recall

All 2 as Truphatek International, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062523Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles…Mar 1, 2007

Other applicant names beginning “Truphatek”

FDA records each applicant name separately; these may or may not be the same firm.

Truphatek, Ltd. 4