510(k) Report

FDA applicant

Tfx Medical, Inc.

Jaffrey, NH4 decisions2000–20020 recalls

FDA records 4 decisions for Tfx Medical, Inc. (Jaffrey, NH) from 2000 to 2002: 4 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 9 predicates, 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Tfx Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tfx Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tfx Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • DYBIntroducer, Catheter1decision

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 2 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.

  • K000665TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 20005cite it
  • K993191TFX Medical Introducer AssemblyTfx Medical, Inc. · 20004cite it
  • K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
  • K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
  • K000665TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2000
  • K993191TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000

All 4 as Tfx Medical, Inc. →