510(k) · Cleared
ClearedK-Defib/Pace Radiolucent Adult Electrode, Model KRT-60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Katecho, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Aug 23, 1999 after a 150-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 23, 1999
- Review
- 150 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- 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.
Planning a device in MKJ? 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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The Katecho External Radiolucent electrode is indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KRT-60 Radiclucent electrode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires…
Read the full statement (122 words)
The Katecho External Radiolucent electrode is indicated for use in external Pacing,
Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient
use, only. The KRT-60 Radiclucent electrode provides the conductive interface between the
defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the
patients skin. The electrode is intended for use on adult patients.
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will
be applied to the patient and connected to the instrument. This devics is intended for use on
defibrillators whose output is classified as low power (360 Joule maximum).
This device has been tested to the ANSI/AAMI DF2-1996 standard for use with equipment:
Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-
Packard.
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/K991007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991007: K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991007
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026