510(k) · Cleared

Recalled · 2009

Zoll Aed Plus

K033474510(k) TraditionalCleared May 21, 2004200-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 Corp · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on May 21, 2004 as substantially equivalent to K022732 (Medtronic Physio-Control Corp., 2002) after a 200-day review. Its family tree reaches back 2 generations to 2001. 1 of the 75 devices in its family, counting itself, has a Class I recall. 72 later devices descend from it. It has been recalled once.

Decided: May 21, 2004
Review: 200 days
Class: Class III
Product code: MKJ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K003819 (2001). 72 later devices descend from it, 5 citing it directly. 1 of the 75 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
1 generation backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
This deviceK033474 Zoll Aed PlusZoll Medical Corp · 2004
Descendant · cites it directly · 64 of its ownK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
Descendant · 2 generations on · 27 of its ownK090989 Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
Descendant · 3 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
Descendant · cites it directly · 23 of its ownK041892 Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005
Descendant · 2 generations on · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2005high 8 (2011) · low 0 (2007)2026

Class I recalls in this family

K022732 Infant/Child Reduced Energy Electrodesdirect predicate · 2002

Most influential descendants

Showing 5 of 72 · See all

K042007Zoll E Series DefibrillatorZoll Medical Corp · 2005 · cites it directly64descendants
K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009 · 2 generations on27descendants
K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 3 generations on24descendants
K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005 · cites it directly23descendants
K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · 2 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003819	Heartstream Attenuated Defibrillation Pads, Model M3870A	Agilent Technologies, Inc.	2001	4
−1	K022732	Infant/Child Reduced Energy Electrodes	Medtronic Physio-Control Corp.	2002	Class I
0 (this device)	K033474	Zoll Aed Plus	Zoll Medical Corp	2004	—
+1	K042007	Zoll E Series Defibrillator	Zoll Medical Corp	2005	3
+2	K090989	Zoll R Series with Nibp and ETCO2 Options, Zoll R Series	Zoll Medical Corp	2009	—
+3	K151644	Masimo Root Vital Signs Monitoring System and Accessories	Masimo Corporation	2016	—
+1	K041892	Zoll Aed Pro External Defibrillator	ZOLL Medical Corporation	2005	—
+2	K060559	Zoll R Series Defibrillator	ZOLL Medical Corporation	2006	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2008	4	0
2009	5	0
2010	4	0
2011	8	0
2012	6	0
2013	1	0
2014	6	0
2015	5	0
2016	1	0
2017	3	0
2018	2	0
2019	3	0
2020	6	0
2021	2	0
2022	1	0
2023	4	0
2024	5	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K033474, 2001–2026Source: 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
*	K022732	Infant/Child Reduced Energy Electrodes Summary page 2 …Medtronic Physio-Control Infant / Child Reduced Energy Electrodes used with the LIFEPAK CR Plus or biphasic LIFEPAK 500 AEDs cleared under premarket 510(k) notification k022732. Performance Data The ZOLL AED Plus external defibrillator was subject to extensive safety and performance testing prior to rel…	Medtronic Physio-Control Corp.	2002	Class I

Also cleared against K022732: 2 other devices →

What descends from it? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K042007	Zoll E Series Defibrillator	Zoll Medical Corp	2005	64
K041892	Zoll Aed Pro External Defibrillator	ZOLL Medical Corporation	2005	23
K110978	Onestep Pediatric Mfe's	ZOLL Medical Corporation	2011	7
K110154	Zoll Aed Plus with 2010 Aha Guidlines Software Update	Zoll Medical Corporation, World Wide Headquarters	2011	2
K091561	Zoll Aed Plus Version 5.32 Software Release	ZOLL Medical Corporation	2010	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 12, 2009	Not classified	Z-1206-2009	Process design	Device fails to discharge the defibrillation energy.

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.

K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K042007 (Zoll Medical Corp, 2005) has gone furthest, with 64 descendants of its own.
2 other devices also cite its predicate K022732.

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?

Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

Unconsciousness and

Absence of normal breathing and

Absence of a pulse or signs of circulation.

When a victim is less than 8 years of age, or weighs less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response to defibrillate victims of cardiac arrest.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033474 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033474: Zoll Aed Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033474

Report an extraction error

Are you the manufacturer?

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