K-Defib/Pace Multifuction Pediatric Electrode, Model Kdp-70A

• • Terminated Z-0321-06 FDA Unclassified (pre-2012) ·initiated 18 Nov 2005 ·via K003228, on the same 510(k)

  The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K003228 ↗

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 settings is the K-DEFIB/PACE Multifunction Pediatric Electrode primarily intended for use in, and why is this important for me as a clinician?

  The K-DEFIB/PACE Multifunction Pediatric Electrode, Model KDP-70A, is specifically designed for use in clinical settings such as emergency rooms, intensive care units, and operating rooms. This is important because it combines defibrillation and pacing capabilities in a single device, making it ideal for pediatric patients who may require both emergency interventions in critical care environments where quick and precise responses are essential.

• Is the K-DEFIB/PACE Multifunction Pediatric Electrode reusable or single-use, and what does this mean for my inventory management?

  The K-DEFIB/PACE Multifunction Pediatric Electrode is intended for single-use applications only, which means each electrode is designed to be used once and then discarded. This ensures sterility and reduces the risk of cross-contamination, but it also requires you to maintain a steady supply to avoid shortages during emergencies. Since it is supplied sterile, you won’t need to sterilize or reprocess it between uses.

• What types of defibrillator or pacemaker devices is this electrode compatible with, and how do I ensure proper use?

  The K-DEFIB/PACE Multifunction Pediatric Electrode is designed to be used with compatible defibrillator/pacemaker devices—meaning it must be paired with equipment that supports its dual functionality for defibrillation and pacing. Always verify compatibility with your specific device manufacturer’s guidelines to ensure safe and effective use, as improper pairing could lead to malfunctions or reduced performance.

• How should I store the K-DEFIB/PACE Multifunction Pediatric Electrode to maintain its sterility and functionality?

  Since the electrode is supplied sterile, it should be stored in its original, unopened packaging until ready for use. Keep it in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Avoid exposing it to moisture or physical damage, as this could compromise its sterility or performance. Always check the packaging for expiration or integrity before use.

• What regulatory pathway was followed for this device, and how does this affect its use in my facility?

  The K-DEFIB/PACE Multifunction Pediatric Electrode received FDA 510(k) clearance, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms that it meets FDA safety and effectiveness standards for its intended use in pediatric defibrillation and pacing. While this does not require additional facility-specific approvals, you should ensure your facility’s protocols align with FDA guidelines for its use, particularly in emergency scenarios.