K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60

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

510(k) Number

K991007 ↗

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 clinical scenarios is this electrode specifically designed to address in emergency cardiac resuscitation?

  This electrode is designed for delivering defibrillation shocks and temporary pacing to restore a normal heart rhythm during cardiac arrest. It is intended for use with automated external defibrillators (non-wearable) in both clinical settings (like hospitals) and pre-hospital environments (such as ambulances or emergency response sites). Its dual functionality supports both defibrillation (shock delivery) and pacing (temporary electrical stimulation of the heart) to address life-threatening arrhythmias.

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

  The KRT-60 is explicitly labeled as a single-use device, meaning it is intended for one-time use only. Because of this, it is supplied sterile to ensure patient safety during emergency cardiac resuscitation. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and increase infection risks.

• What storage conditions are required to maintain the electrode’s integrity before use?

  The electrode must be stored in a dry, protected environment until use. This prevents moisture damage, which could affect its performance or sterility. Since it is radiolucent (visible under X-ray), it should also be stored away from sources of radiation to avoid potential degradation.

• Can this electrode be used in patients who require imaging (e.g., X-ray or CT scans) during resuscitation?

  No, this electrode is radiolucent, meaning it allows X-rays to pass through, but it is not MRI-safe. While it can be used during X-ray or CT imaging, it should not be used in MRI environments due to potential risks from magnetic fields. Always verify compatibility with imaging equipment before use.

• How do I confirm this electrode is compatible with my defibrillator before use?

  The KRT-60 is designed specifically for automated external defibrillators (non-wearable) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. To confirm compatibility, check your defibrillator’s manufacturer guidelines or contact their technical support. Since it is a Class III device, it should be used only with devices explicitly approved for its intended purpose—never assume compatibility without verification.