510(k) Report

FDA applicant

Lifetek Medical, Inc.

Deforest, WI2 decisions1994–19990 recalls

FDA records 2 decisions for Lifetek Medical, Inc. (Deforest, WI) from 1994 to 1999: 2 510(k) clearances. Most are in product codes MFD (Cannula, Intrauterine Insemination) and MQE (Needle, Assisted Reproduction). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lifetek Medical, 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?

  • MFDCannula, Intrauterine Insemination1decision
  • MQENeedle, Assisted Reproduction1decision

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.

  • K921518Lifetek Iui CatheterLifetek Medical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K992308Oocyte Retrieval Needle Set, Model 90138Lifetek Medical, Inc. · 1999
  • K921518Lifetek Iui CatheterLifetek Medical, Inc. · 1994

All 2 as Lifetek Medical, Inc. →