510(k) · Cleared
ClearedZoll Aed Plus with 2010 Aha Guidlines Software Update
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 Feb 17, 2011 as substantially equivalent to K033474 (Zoll Medical Corp, 2004) after a 29-day review. Its family tree reaches back 3 generations to 2001. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 29 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003819 (2001). 2 later devices descend from it, 1 citing it directly. 1 of the 6 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 deviceK110154 Zoll Aed Plus with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 2011
- Descendant · cites it directly · 1 of its ownK120406 Zoll Fully Automatic Aed PlusZoll Medical Corporation, World Wide Headquarters · 2012
- Descendant · 2 generations on · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes2 generations back · 2002
Most influential descendants
Showing 2 of 2 · See allView 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) | K110154 | Zoll Aed Plus with 2010 Aha Guidlines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| +1 | K120406 | Zoll Fully Automatic Aed Plus | Zoll Medical Corporation, World Wide Headquarters | 2012 | — |
| +2 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K033474 | Zoll Aed PlusSummary page 1…FR 870.5310) Cardiopulmonary Resuscitation Aid: Class 111 (21 CFR 870.5200) Description: The ZOLL AEDPIus was cleared by the agency under 510O(k) application K033474. The device is a lightweight, portable, battery-powered semi-automatic external dlefibrillator that uses voice prompts and visual… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120406 | Zoll Fully Automatic Aed Plus | 2012 | 1 |
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 10 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.
- Of its descendants, K120406 (Zoll Medical Corporation, World Wide Headquarters, 2012) has gone furthest, with 1 descendant of its own.
- 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. 2011, 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 thank 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/K110154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110154: Zoll Aed Plus with 2010 Aha Guidlines Software Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110154
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