Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

510(k) K012218

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK012218	Date12 Oct 2001Cleared	StatusActive

8 recalls · FDA

2 recalls, same reason
- Terminated Z-2546-2015 FDA Class II initiated 19 Aug 2015
- Terminated Z-2545-2015 FDA Class II initiated 19 Aug 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 clinician burns
3 recalls, same reason
- Terminated Z-0048-2015 FDA Class I initiated 18 Sep 2014
- Terminated Z-0045-2015 FDA Class I initiated 18 Sep 2014
- Terminated Z-0044-2015 FDA Class I initiated 18 Sep 2014
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
- Terminated Z-0043-2015 FDA Class I initiated 18 Sep 2014
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
2 recalls, same reason
- Terminated Z-1185-2013 FDA Class II initiated 8 Apr 2013
- Terminated Z-1184-2013 FDA Class II initiated 8 Apr 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

1 jurisdiction

United States — FDA 510(k) Active

510(k)