510(k) Report

FDA applicant

Tfx Medical Group

Jeffrey, NH3 decisions1996–20000 recalls

FDA records 3 decisions for Tfx Medical Group (Jeffrey, NH) from 1996 to 2000: 3 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DRB (Stylet, Catheter). Its devices cite 20 predicates, 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, cardiovascular panel, where it files most

How often FDA has decided Tfx Medical Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tfx Medical Group since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tfx Medical Group 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?

  • DQXWire, Guide, Catheter1decision
  • DRBStylet, Catheter1decision
  • DYBIntroducer, Catheter1decision

Whose devices does it build on?

Its devices cite 20 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K963320TFX Medical GuidewireTfx Medical Group · 19964cite it
  • K992664TFX Medical Stylet CatheterTfx Medical Group · 20001cites it

What has FDA decided for it lately?

  • K992664TFX Medical Stylet CatheterTfx Medical Group · 2000
  • K991647TFX Medical Introducer KitTfx Medical Group · 2000
  • K963320TFX Medical GuidewireTfx Medical Group · 1996

All 3 as Tfx Medical Group →