510(k) · Cleared
ClearedZoll Fully Automatic Aed Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corporation, World Wide Headquarters · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Oct 26, 2012 as substantially equivalent to K110154 (Zoll Medical Corporation, World Wide Headquarters, 2011) after a 260-day review. Its family tree reaches back 4 generations to 2001. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 26, 2012
- Review
- 260 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003819 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- 3 generations backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- 2 generations backK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
- 1 generation backK110154 Zoll Aed Plus with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
- This deviceK120406 Zoll Fully Automatic Aed PlusZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · cites it directly · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes3 generations back · 2002
Most influential descendants
Showing 1 of 1 · See all- K143714Powerheart G5 AEDCardiac Science Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| −3 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| −2 | K033474 | Zoll Aed Plus | Zoll Medical Corp | 2004 | 1 |
| −1 | K110154 | Zoll Aed Plus with 2010 Aha Guidlines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| 0 (this device) | K120406 | Zoll Fully Automatic Aed Plus | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +1 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 |
|---|---|---|---|
| * | K110154 | Zoll Aed Plus with 2010 Aha Guidlines Software UpdateSummary page 2…age or weight. Substantial Equivalence: The features and functions of the new ZOLL Fully Automatic AED Plus are substantially equivalent to the predicate ZOLL AED Plus (K1 10154, cleared for use on 2/17/20 11). Comparison of Technological Characteristics The technological characteristics of the new ZOLL F… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143714 | Powerheart G5 AED | 2015 | 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.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143714 (Cardiac Science Corporation, 2015) has gone furthest, with 0 descendants of its own.
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. 2012, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120406: Zoll Fully Automatic Aed Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120406
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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