K-Defib/Pace Adult Electrode, Model KDP-80

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K993745 ↗

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 →

• Are these electrodes reusable or meant for single-use only, and why does that matter in emergency settings?

  The K-Defib/Pace Adult Electrode (Model KDP-80) is explicitly designed for single-use only. This is critical in emergency settings because single-use electrodes eliminate cross-contamination risks between patients, ensuring sterility and reducing infection hazards. Reusing electrodes could compromise patient safety by introducing pathogens or degrading performance due to repeated use.

• What storage conditions are required for these electrodes, and how should they be handled before use?

  The electrodes require no special storage conditions beyond protecting them from physical damage. They are supplied sterile and individually packaged, so they can be stored at room temperature. However, it’s important to avoid exposing them to extreme temperatures, moisture, or direct sunlight, as these could compromise sterility or adhesive properties before use.

• Which defibrillation devices are compatible with this electrode, and why is compatibility important?

  The KDP-80 electrodes are specifically compatible with Physio Control defibrillation devices using Quik Combo Electrodes. Compatibility is important because mismatched electrodes may not deliver the correct electrical impulse strength or adhere properly, potentially leading to ineffective defibrillation or pacing. Always verify device compatibility to ensure optimal performance during emergencies.

• How do I know if these electrodes are suitable for adult patients, and what makes them different from pediatric versions?

  These electrodes are explicitly labeled for adult patients and are not intended for pediatric use. While the data doesn’t specify exact size differences, the term *adult* implies they are designed for larger chest sizes and higher energy delivery requirements compared to pediatric electrodes, which are typically smaller and optimized for lower voltage applications. Always confirm patient age and size before use.

• What does the FDA 510(k) clearance mean for this device, and how does it affect my purchasing decision?

  The FDA 510(k) clearance (K993745) under regulation 870.5310 confirms that the KDP-80 electrodes have been deemed substantially equivalent to a legally marketed predicate device, meaning they meet FDA safety and effectiveness standards for defibrillation and pacing applications. This clearance ensures the device has undergone rigorous testing and regulatory review, giving confidence in its performance and reliability for emergency use.