510(k) · Cleared

Cleared

K-Defib/Pace, Model KDP-60A

K002806510(k) TraditionalCleared Nov 21, 200074-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 Nov 21, 2000 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.

Decided: Nov 21, 2000
Review: 74 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 0

4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

This deviceK002806 K-Defib/Pace, Model KDP-60AKatecho, Inc. · 2000
Descendant · cites it directly · 2 of its ownK014209 Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 2002 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK103186 Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011
Descendant · cites it directly · 0 of its ownK042088 Samaritan Pad Pak Defibrillation Electrode, Model SPP-301Heartsine Technologies, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK020743 Padpro, Model 2502Padpro, LLC · 2002

Class I recalls in this family

K014209 Padpro Model 2001, 2001-S, 2001-C, 2001-Epscites it directly · 2002

Most influential descendants

Showing 4 of 4 · See all

K014209Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 2002 · cites it directly2descendants
K103186Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011 · 2 generations on0descendants
K042088Samaritan Pad Pak Defibrillation Electrode, Model SPP-301Heartsine Technologies, Inc. · 2004 · cites it directly0descendants
K020743Padpro, Model 2502Padpro, LLC · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002806	K-Defib/Pace, Model KDP-60A	Katecho, Inc.	2000	—
+1	K014209	Padpro Model 2001, 2001-S, 2001-C, 2001-Eps	Padpro, LLC	2002	Class I
+2	K103186	Skintact Radiotransparent Multifunction Electrodes	Leonhard Lang GmbH	2011	—
+1	K042088	Samaritan Pad Pak Defibrillation Electrode, Model SPP-301	Heartsine Technologies, Inc.	2004	—
+2	K020743	Padpro, Model 2502	Padpro, LLC	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	1
2004	1	0
2011	1	0

FIG. 1 — Lineage of K002806, 2000–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K014209	Padpro Model 2001, 2001-S, 2001-C, 2001-Eps Class I	Padpro, LLC	2002	2
K042088	Samaritan Pad Pak Defibrillation Electrode, Model SPP-301	Heartsine Technologies, Inc.	2004	0

Has anything in its family been recalled? (1 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.

K014209Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Of its descendants, K014209 (Padpro, LLC, 2002) has gone furthest, with 2 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	—

https://510kreport.com/device/K002806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002806: K-Defib/Pace, Model KDP-60A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002806

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026