K-Defib/Pace Pediatric Electrode
by Katecho LLC 510(k)
Active
510(k) K934692
Overview
The K-Defib/Pace Pediatric Electrode is a disposable adhesive electrode designed for use with automated external defibrillators (non-wearable) and external pacemakers. It is specifically engineered for pediatric patients, providing precise defibrillation and pacing capabilities in emergency cardiac situations.
This single-use electrode is supplied sterile and intended for use in prehospital and clinical settings where rapid defibrillation or pacing is required. It adheres to FDA 510(k) clearance (K934692) under regulation number 870.5310, classified as a Class III device. The product code MKJ identifies its administrative filing category, and it is not intended for MRI environments. Storage follows standard sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934692 | Date24 Jan 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- 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
Other devices from Katecho LLC
Questions
What is the primary use case for the K-Defib/Pace Pediatric Electrode in emergency settings?
The K-Defib/Pace Pediatric Electrode is specifically designed for pediatric patients in emergency cardiac situations, providing precise defibrillation and pacing capabilities. It is intended for use with automated external defibrillators (non-wearable) and external pacemakers in both prehospital and clinical settings where rapid intervention is critical.
Is this electrode reusable or single-use, and how should it be stored?
The K-Defib/Pace Pediatric Electrode is a single-use device, supplied sterile to ensure safety and reliability in emergency scenarios. Storage follows standard sterile medical device protocols, meaning it should be kept in a clean, dry environment, protected from contamination, and used within the manufacturer’s recommended shelf life.
What regulatory pathway was followed for FDA clearance, and what does that mean for its classification?
The device received FDA clearance via a 510(k) submission (K934692), classified as a Class III device under regulation number 870.5310. This classification indicates it is intended for life-supporting or life-sustaining purposes, and the clearance was determined through a traditional review process by the FDA’s Cardiovascular (CV) Advisory Committee.
Can this electrode be used in an MRI environment, and if not, why?
No, the K-Defib/Pace Pediatric Electrode is not intended for use in MRI environments. This restriction is explicitly stated in the device’s documentation, likely due to potential interference with MRI magnetic fields or safety concerns related to metallic components in the electrode.
What sizes or models are available for the K-Defib/Pace Pediatric Electrode, and how does that differ from adult electrodes?
The device is specifically engineered for pediatric patients, though exact sizing details (e.g., dimensions or pad configurations) are not provided in the data. Unlike adult electrodes, it is designed to accommodate smaller chest sizes, ensuring proper defibrillation and pacing efficacy in children. For precise sizing, refer to the manufacturer’s packaging or instructions for use.