510(k) Report

FDA applicant

Pantak, Inc.

Branford, CT2 decisions1997–19970 recalls

FDA records 2 decisions for Pantak, Inc. (Branford, CT) in 1997: 2 510(k) clearances. All are in product code JAD (System, Therapeutic, X-Ray). 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, radiology panel, where it files most

How often FDA has decided Pantak, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pantak, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pantak, 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?

  • JADSystem, Therapeutic, X-Ray2decisions

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.

  • K971074Therapax SXT 150Pantak, Inc. · 19972cite it

What has FDA decided for it lately?

  • K973315Therapax DXT 300 Model HF-300Pantak, Inc. · 1997
  • K971074Therapax SXT 150Pantak, Inc. · 1997

All 2 as Pantak, Inc. →