510(k) · Cleared
ClearedZoll Aed Plus Version 5.32 Software Release
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 23, 2010 as substantially equivalent to K033474 (Zoll Medical Corp, 2004) after a 483-day review. Its family tree reaches back 3 generations to 2001. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 23, 2010
- Review
- 483 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003819 (2001). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- 2 generations backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- 1 generation backK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
- This deviceK091561 Zoll Aed Plus Version 5.32 Software ReleaseZOLL Medical Corporation · 2010
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes2 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| −2 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| −1 | K033474 | Zoll Aed Plus | Zoll Medical Corp | 2004 | 1 |
| 0 (this device) | K091561 | Zoll Aed Plus Version 5.32 Software Release | ZOLL Medical Corporation | 2010 | — |
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
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 | Decided |
|---|---|---|---|
| * | K033474 | Zoll Aed PlusSummary page 2…The features and functions of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005). Comparison of Technological Characteristics The technological characteristics of the proposed… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K033474.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 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 AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. 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…
Read the full statement (122 words)
The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. 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 a child or infant less than 8 years of age, or 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091561: Zoll Aed Plus Version 5.32 Software Release.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091561
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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