510(k) · Cleared
Recalled · Class I · 2015Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Ludlow Company LP · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Cleared on Oct 12, 2001 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has a Class I recall. It has been recalled 8 times, including 4 Class I recalls.
- Decided
- Oct 12, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- DRO
- Recalls
- 8 (4 Class I)
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2015 | Class II | Z-2545-2015 | Process control | 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 |
| Aug 19, 2015 | Class II | Z-2546-2015 | Process control | 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 |
| Sep 18, 2014 | Class I | Z-0043-2015 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Process control | 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 | Process control | 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 |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DRO devicesDRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRO
FDA has decided no DRO device since 2007.
Median 510(k) review, days · DRO
Too few DRO 510(k)s in any year since 2007 to give a median.
Recalls per year · DRO
12in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DRO
2in 2025
MAUDE reports naming product code DRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 4 (4) | 2 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 64 |
| 2019 | 0 | — | 0 | 93 |
| 2020 | 0 | — | 12 | 19 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012218: Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026