K-Defib/Pace Adult Electrode Model Number KDP-60

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981737 ↗

FDA Product Code

MKJ

FDA applicant

Katecho, Inc.

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• K-Sterile Tens Electrodes

  Class II

  FDA 510(k) K900997 Active Cleared 13 Mar 1990

• K-Defib/Pace Pediatric Electrode

  Class III

  FDA 510(k) K934692 Active Cleared 24 Jan 1995

• K-Stim Clear

  Class II

  FDA 510(k) K922202 Active Cleared 17 May 1993

• K-Defib/Pace Electrode

  Class II

  FDA 510(k) K914955 Active Cleared 14 May 1992

• K-Free

  Class II

  FDA 510(k) K912587 Active Cleared 30 Jul 1991

• KM-10 TENS Electrode

  Class II

  FDA 510(k) K000870 Active Cleared 7 Nov 2000

See all devices from Katecho LLC →

• What types of cardiac emergencies is this electrode designed to address, and how does it work in those situations?

  The K-DEFIB/PACE ADULT ELECTRODE (Model KDP-60) is specifically designed to deliver defibrillation shocks and pacing pulses to restore normal heart rhythm during cardiac emergencies like ventricular fibrillation or ventricular tachycardia. It achieves this by attaching to the patient’s chest to deliver controlled electrical impulses that interrupt abnormal heart rhythms and help the heart resume a regular beat.

• Is this electrode reusable, or is it intended for single-use only? How does that affect its sterility?

  The K-DEFIB/PACE ADULT ELECTRODE (Model KDP-60) is explicitly labeled as a single-use device. Because of this, it is supplied sterile out of the package, ensuring safety and reliability for immediate use in pre-hospital, emergency medical, or clinical settings without the need for reprocessing.

• Can this electrode be used safely in environments with MRI machines, and how should it be stored?

  Yes, the K-DEFIB/PACE ADULT ELECTRODE (Model KDP-60) adheres to MRI safety standards for non-ferromagnetic materials, meaning it can be used in MRI environments without interference. For storage, it should be kept in its original packaging until ready for use, as it is designed for immediate deployment upon opening.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its safety and reliability?

  The electrode received FDA 510(k) clearance through a traditional review process, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. This means the device met FDA standards for safety and effectiveness by demonstrating equivalence to a legally marketed predicate device, ensuring its reliability for defibrillation and pacing applications in adult cardiac emergencies.