510(k) · Cleared

Recalled · Class I · 2014

Padpro Model 2001, 2001-S, 2001-C, 2001-Eps

K014209510(k) SpecialCleared Jan 18, 200228-day reviewClass III21 CFR 870.5310Recalls 4 (3 Class I)

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

Padpro, LLC · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jan 18, 2002 as substantially equivalent to K002806 (Katecho, Inc., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.

Decided: Jan 18, 2002
Review: 28 days
Class: Class III
Product code: MKJ
Recalls: 4 (3 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K002806 (2000). 2 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK002806 K-Defib/Pace, Model KDP-60AKatecho, Inc. · 2000
This deviceK014209 Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 2002
Descendant · cites it directly · 0 of its ownK103186 Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011
Descendant · cites it directly · 0 of its ownK020743 Padpro, Model 2502Padpro, LLC · 2002

Most influential descendants

Showing 2 of 2 · See all

K103186Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011 · cites it directly0descendants
K020743Padpro, Model 2502Padpro, LLC · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002806	K-Defib/Pace, Model KDP-60A	Katecho, Inc.	2000	—
0 (this device)	K014209	Padpro Model 2001, 2001-S, 2001-C, 2001-Eps	Padpro, LLC	2002	—
+1	K103186	Skintact Radiotransparent Multifunction Electrodes	Leonhard Lang GmbH	2011	—
+1	K020743	Padpro, Model 2502	Padpro, LLC	2002	—

Descendants by year cleared

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

FIG. 1 — Lineage of K014209, 2000–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K002806	K-Defib/Pace, Model KDP-60A Summary page 1 …ctrocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode . Equivalent legally marketed device: This identical in function to the Katecho KDP-60A (K002806) and nearly identical in design. . Indications for Use: The PadPro radiotransparent external electrodes are indicated for use in…	Katecho, Inc.	2000	—

Also cleared against K002806: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K103186	Skintact Radiotransparent Multifunction Electrodes	Leonhard Lang GmbH	2011	0
K020743	Padpro, Model 2502	Padpro, LLC	2002	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 6, 2014	Class I	Z-0455-2015	Device Design	Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient…
Nov 6, 2014	Class I	Z-0454-2015	Device Design	Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient…
Nov 6, 2014	Class I	Z-0456-2015	Device Design	Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient…
May 3, 2013	Class II	Z-1317-2013	Component design/selection	ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K103186 (Leonhard Lang GmbH, 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K002806.

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 PadPro radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s 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 device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014209 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014209: Padpro Model 2001, 2001-S, 2001-C, 2001-Eps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014209

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026