510(k) · Cleared

Cleared

K-Defib/Pace Adult Electrode Model Number KDP-60

K981737510(k) TraditionalCleared Dec 9, 1998205-day reviewClass III21 CFR 870.5310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Katecho, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Dec 9, 1998 after a 205-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 15 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.

Decided: Dec 9, 1998
Review: 205 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 0

14 later devices descend from it, 6 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

This deviceK981737 K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 1998
Descendant · cites it directly · 6 of its ownK013896 Sentry Semiautomatic External Defibrillator; External Defibrillation…Defibtech, LLC · 2002 · Recalled
Descendant · cites it directly · 5 of its ownK020203 Padpro Model #2516Padpro, LLC · 2002 · Recalled (Class I)
Descendant · cites it directly · 4 of its ownK080421 Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Recalled (Class I)
Descendant · 2 generations on · 3 of its ownK081259 Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009
Descendant · 3 generations on · 0 of its ownK131525 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

1999high 3 (2011) · low 0 (2000)2026

Class I recalls in this family

K080421 Heart Sync, Models C-100 and T-100cites it directly · 2008
K020203 Padpro Model #2516cites it directly · 2002

Most influential descendants

Showing 5 of 14 · See all

K013896Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…Defibtech, LLC · 2002 · cites it directly6descendants
K020203Padpro Model #2516Padpro, LLC · 2002 · cites it directly5descendants
K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · cites it directly4descendants
K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009 · 2 generations on3descendants
K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K981737	K-Defib/Pace Adult Electrode Model Number KDP-60	Katecho, Inc.	1998	—
+1	K013896	Sentry Semiautomatic External Defibrillator; External Defibrillation Pads…	Defibtech, LLC	2002	5
+1	K020203	Padpro Model #2516	Padpro, LLC	2002	Class I
+1	K080421	Heart Sync, Models C-100 and T-100	Heart Sync, LLC	2008	Class I
+2	K081259	Ddu-2300 Semiautomatic External Defibrillator and Accessories	Defibtech, LLC	2009	—
+3	K131525	Semiautomatic External Defibrillator and Accessories	Defibtech, LLC	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	2	1
2008	2	1
2009	1	0
2011	3	0
2012	2	0
2013	2	0
2014	1	0

FIG. 1 — Lineage of K981737, 1998–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have 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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (14)

See all 14

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013896	Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…	Defibtech, LLC	2002	6
K020203	Padpro Model #2516 Class I	Padpro, LLC	2002	5
K080421	Heart Sync, Models C-100 and T-100 Class I	Heart Sync, LLC	2008	4
K103334	Cardio Med	Cardio Medical Products, Inc.	2011	0
K103159	Cardio Med Model A102, H104, O101, P103, and Z100	Cardio Medical Products, Inc.	2011	0
K993072	Survivalink Multifunctional Electrode (SVL-9630)	Survivalink Corp.	1999	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K080421Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 15 Class I recalls
K020203Padpro Model #2516Padpro, LLC · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K013896 (Defibtech, LLC, 2002) has gone furthest, with 6 descendants of its own.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKJ

48in 2025

2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007high 17,062 (2016) · low 3,958 (2007)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 “K-Defib/Pace Adult Electrode it is indicated for use in cxternal Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. ‘I'he KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrodc is intended for use on adult patients. When a patient…

Read the full statement (126 words)

When a patient requires defibrillation or external pacing these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joulc maximum),

This device has been tested to the ANSI/AAMI DF39-1993 standard for use with equipment by the following manufacturers; 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/K981737 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981737: K-Defib/Pace Adult Electrode Model Number KDP-60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981737

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026