# K012218: Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: The Ludlow Company LP
- Decided: Oct 12, 2001 after 88 days
- Product code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))
- Device class: 2
- Regulation: 21 CFR 870.5550
- Recalls of this device: 8 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 19, 2015 · Class II · Z-2545-2015: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clini
- Aug 19, 2015 · Class II · Z-2546-2015: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clini
- Sep 18, 2014 · Class I · Z-0043-2015: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
- Sep 18, 2014 · Class I · Z-0048-2015: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
- Sep 18, 2014 · Class I · Z-0044-2015: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
- Sep 18, 2014 · Class I · Z-0045-2015: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
- Apr 8, 2013 · Class II · Z-1184-2013: Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
- Apr 8, 2013 · Class II · Z-1185-2013: Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient

## Indications for use
The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring. The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only. The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.

Source page: https://510kreport.com/device/K012218
Methodology: https://510kreport.com/methodology