510(k) · Cleared

Recalled · 2011

Zoll Pedipadz Reduced Energy Electrode

K072430510(k) TraditionalCleared Nov 6, 200769-day reviewClass III21 CFR 870.5310Recalls 1

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

ZOLL Medical Corporation · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Nov 6, 2007 as substantially equivalent to K915159 (Zmi Corp., 1992) and 1 other predicate after a 69-day review. Its family tree reaches back 5 generations to 1997. It has been recalled once.

Decided: Nov 6, 2007
Review: 69 days
Class: Class III
Product code: MKJ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 5 generations to K970741 (1997). 8 ancestors in all, the oldest K915159 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
4 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
3 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
2 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
1 generation backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
This deviceK072430 Zoll Pedipadz Reduced Energy ElectrodeZOLL Medical Corporation · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K970741	Powerheart Aecd	Cardiac Science, Inc.	1997	1
−4	K982710	Aecd Arrhythmia Detection Software	Cardiac Science, Inc.	1998	1
−3	K993533	Powerheart Aecd	Cardiac Science, Inc.	2000	1
−2	K011901	Firstsave Star Biphasic, Model 9210/9200	Survivalink Corp.	2002	2
−1	K022929	Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed…	Cardiac Science, Inc.	2003	—
0 (this device)	K072430	Zoll Pedipadz Reduced Energy Electrode	ZOLL Medical Corporation	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
2001	2	0

FIG. 1 — Lineage of K072430, 1997–2007Source: 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.

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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K915159	Pediatric Multi-Function Electrodes Summary page 1 …features and functions of the ZOLL pedi.padz'M Reduced Energy Electrode are substantially equivalent to those of the ZOLL pedi.padz TM Multifunction Electrode K915159A, cleared 02/07/1992, and the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes K022929, cleared 01/…	Zmi Corp.	1992	1
*	K022929	Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model… Summary page 1 …f the ZOLL pedi.padz TM Multifunction Electrode K915159A, cleared 02/07/1992, and the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes K022929, cleared 01/27/2003. Description: The disposable ZOLL pedi.padzT M Reduced Energy Electrode is specifically designed f…	Cardiac Science, Inc.	2003	—

Also cleared against K915159: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 30, 2011	Not classified	Z-1011-2012	Process control	Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
7 of the 8 ancestors have a recall of any class.
1 other device also cites its predicate K915159.

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. 2007, this device’s year, is highlighted.

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 ZOLL pediopadzTM Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg). The ZOLL pediopadzT M Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have…

Read the full statement (134 words)

The ZOLL pediopadzTM Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg).

The ZOLL pediopadzT M Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

Unconsciousness

Absence of breathing

Absence of pulse.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072430 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072430: Zoll Pedipadz Reduced Energy Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072430

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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