510(k) Report

FDA applicant

Katecho, Inc.

Des Moines, IA26 decisions1984–20011 recall

FDA records 26 decisions for Katecho, Inc. (Des Moines, IA) from 1984 to 2001: 26 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and DRO (Pacemaker, Cardiac, External Transcutaneous…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Katecho, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Katecho, 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?

  • MKJAutomated External Defibrillators (Non-Wearable)7decisions
  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)4decisions
  • GXYElectrode, Cutaneous4decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)4decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief3decisions
  • DRXElectrode, Electrocardiograph2decisions

Also: ELE (1).

Who builds on its devices?

Later devices cite its devices 13 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.

  • K981737K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 19986cite it
  • K000870KM-10 Tens ElectrodeKatecho, Inc. · 20002cite it
  • K002806K-Defib/Pace, Model KDP-60AKatecho, Inc. · 20002cite it
  • K914955K-Defib/Pace ElectrodeKatecho, Inc. · 19921cites it
  • K900997K-Sterile Tens ElectrodesKatecho, Inc. · 19901cites it
  • K954504K-Defib/Pace Pediatric ElectrodeKatecho, Inc. · 19951cites it

What has FDA decided for it lately?

  • K012404K-Defib/Pace Adult Electrode, Model KDP-85Katecho, Inc. · 2001
  • K010543KM-30 Tens ElectrodeKatecho, Inc. · 2001
  • K003228K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AKatecho, Inc. · 20001 recall
  • K002806K-Defib/Pace, Model KDP-60AKatecho, Inc. · 2000
  • K000870KM-10 Tens ElectrodeKatecho, Inc. · 2000
  • K993745K-Defib/Pace Adult Electrode, Model KDP-80Katecho, Inc. · 2000
  • K991007K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60Katecho, Inc. · 1999
  • K981737K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 1998

All 26 as Katecho, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K003228HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode…Nov 18, 2005